Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-25 @ 12:48 PM
Study NCT ID:
NCT03226067
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576694', 'term': 'setanaxib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.philipson@calliditas.com', 'phone': 'Desk: +46 556659-9766', 'title': 'Richard Philipson, MD Chief Medical Officer', 'organization': 'Calliditas Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '.Approximately 6-7 months', 'description': 'Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 28-day follow-up period after the last administration of IMP', 'eventGroups': [{'id': 'EG000', 'title': 'GKT137831 400mg Twice Daily', 'description': 'GKT137831 400mg twice daily\n\nPatients will self-administer 4 capsules in the morning and 4 capsules in the evening.\n\nGKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 32, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GKT137831 400mg Once Daily', 'description': 'GKT137831 400mg once daily\n\nPatients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos.\n\nGKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.\n\nPlacebo oral capsule: Matching capsules.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 34, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Arm', 'description': 'Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos.\n\nPlacebo oral capsule: Matching capsules.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 31, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrooesoghageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Multiple Fractures', 'notes': 'In the Setanaxib 400 mg BID arm: One (2.8%) subject experienced CTCAE grade 3 multiple fractures, resulting from a road traffic accident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary Infection', 'notes': 'One (2.7%) subject in the placebo arm experienced CTCAE grade 1 urinary tract infection. This was considered unrelated to study medication by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percent Change in Serum GGT.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'spread': '59.58', 'groupId': 'OG000'}, {'value': '-19', 'spread': '28.89', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '21.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24 (visit 7)', 'description': 'Percent change in serum GGT from baseline to Week 24 (serum GGT was measured in U/L)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Serum GGT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Absolute change W2', 'categories': [{'measurements': [{'value': '-14.3', 'spread': '112.66', 'groupId': 'OG000'}, {'value': '-48.5', 'spread': '61.83', 'groupId': 'OG001'}, {'value': '-11.2', 'spread': '45.96', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W6', 'categories': [{'measurements': [{'value': '-22.2', 'spread': '76.68', 'groupId': 'OG000'}, {'value': '-53.5', 'spread': '67.57', 'groupId': 'OG001'}, {'value': '-17.9', 'spread': '59.01', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W12', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '115.13', 'groupId': 'OG000'}, {'value': '-50.6', 'spread': '74.7', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '70.11', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W18', 'categories': [{'measurements': [{'value': '-19.2', 'spread': '134.32', 'groupId': 'OG000'}, {'value': '-37.9', 'spread': '93.88', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '79.81', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W24', 'categories': [{'measurements': [{'value': '-17.9', 'spread': '117.62', 'groupId': 'OG000'}, {'value': '-43.6', 'spread': '62.22', 'groupId': 'OG001'}, {'value': '-10.7', 'spread': '78.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum GGT from baseline to each assessment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum GGT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change W2', 'categories': [{'measurements': [{'value': '-7', 'spread': '25.08', 'groupId': 'OG000'}, {'value': '-17', 'spread': '17.25', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '13.04', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W6', 'categories': [{'measurements': [{'value': '-11.8', 'spread': '21.59', 'groupId': 'OG000'}, {'value': '-22', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '16.89', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W12', 'categories': [{'measurements': [{'value': '1.7', 'spread': '66.84', 'groupId': 'OG000'}, {'value': '-18.6', 'spread': '27.44', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '19.44', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W18', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '69.65', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '28.55', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '22.79', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W24', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '59.58', 'groupId': 'OG000'}, {'value': '-19', 'spread': '28.89', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '21.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in serum GGT from baseline to each assessment (serum GGT was measured in U/L)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change W2', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '12.71', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '11.51', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W6', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '13.42', 'groupId': 'OG000'}, {'value': '-16.3', 'spread': '13.32', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '15.19', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W12', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '22.17', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '17.89', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '16.41', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W18', 'categories': [{'measurements': [{'value': '-7.8', 'spread': '21.68', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '21.42', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '15.66', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W24', 'categories': [{'measurements': [{'value': '-9.7', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '19.55', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '15.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in serum ALP from baseline to each assessment (serum ALP was measured in U/L).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Serum ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Absolute change W2', 'categories': [{'measurements': [{'value': '-19.8', 'spread': '35.95', 'groupId': 'OG000'}, {'value': '-45.9', 'spread': '75.75', 'groupId': 'OG001'}, {'value': '-17', 'spread': '44.4', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W6', 'categories': [{'measurements': [{'value': '-27.3', 'spread': '44.13', 'groupId': 'OG000'}, {'value': '-58.6', 'spread': '63.88', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '59.72', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W12', 'categories': [{'measurements': [{'value': '-15.3', 'spread': '67.79', 'groupId': 'OG000'}, {'value': '-53', 'spread': '66.51', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '52.75', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W18', 'categories': [{'measurements': [{'value': '-27.6', 'spread': '62.54', 'groupId': 'OG000'}, {'value': '-53.2', 'spread': '80.01', 'groupId': 'OG001'}, {'value': '-6', 'spread': '50.15', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W24', 'categories': [{'measurements': [{'value': '-32.5', 'spread': '65.3', 'groupId': 'OG000'}, {'value': '-45.2', 'spread': '84.41', 'groupId': 'OG001'}, {'value': '-12.4', 'spread': '53.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum ALP from baseline to each assessment.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Serum Conjugated Bilirubin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Absolute change W2', 'categories': [{'measurements': [{'value': '0', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W6', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W12', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Absolue change W18', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '1.91', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W24', 'categories': [{'measurements': [{'value': '1.1', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum conjugated bilirubin from baseline to each assessment.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Conjugated Bilirubin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change W2', 'categories': [{'measurements': [{'value': '0.9', 'spread': '16.81', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '22.79', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '28.11', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W6', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '29.4', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '17.99', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W12', 'categories': [{'measurements': [{'value': '9.4', 'spread': '27.14', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '18.55', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '20.81', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W18', 'categories': [{'measurements': [{'value': '6.0', 'spread': '28.16', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '19.34', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '25.98', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W24', 'categories': [{'measurements': [{'value': '12.7', 'spread': '36.35', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '24.85', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '32.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in serum Conjugated bilirubin, from baseline to each assessment (serum conjugated bilirubin is measured in μmol/L).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Serum Total Bilirubin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Absolute change W2', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '3.75', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W6', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '3.39', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '3.29', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W12', 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '2.21', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W18', 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '3.81', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W24', 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.71', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '3.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum total bilirubin, from baseline to each assessment.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Total Bilirubin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change W2', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '23.62', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '32.42', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '39.98', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W6', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '21.94', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '41.19', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '34.6', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W12', 'categories': [{'measurements': [{'value': '5.7', 'spread': '32.99', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '37.53', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '22.39', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W18', 'categories': [{'measurements': [{'value': '1.7', 'spread': '28.34', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '32.56', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '29.5', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W24', 'categories': [{'measurements': [{'value': '5.4', 'spread': '29.77', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '31.60', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '32.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in Serum Total Bilirubin from baseline to each assessment (serum total bilirubin is measured in μmol/L).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '5.24', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '3.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Absolute change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24.', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '34.95', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '43.68', 'groupId': 'OG001'}, {'value': '10.1', 'spread': '33.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Percent change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Levels of Collagen Fragments Indicative of Collagen Formation and Degradation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change ProC3 W12', 'categories': [{'measurements': [{'value': '-2.58', 'spread': '21.09', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '18.23', 'groupId': 'OG001'}, {'value': '3.64', 'spread': '27.86', 'groupId': 'OG002'}]}]}, {'title': 'Percent change ProC3 W24', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '22.54', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '18.17', 'groupId': 'OG001'}, {'value': '3.10', 'spread': '20.78', 'groupId': 'OG002'}]}]}, {'title': 'Percent change ProC5 W12', 'categories': [{'measurements': [{'value': '1.17', 'spread': '20.56', 'groupId': 'OG000'}, {'value': '-6.65', 'spread': '22.99', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '22.52', 'groupId': 'OG002'}]}]}, {'title': 'Percent change ProC5 W24', 'categories': [{'measurements': [{'value': '2.26', 'spread': '30.36', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '17.73', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '37.78', 'groupId': 'OG002'}]}]}, {'title': 'Percent change C3M W12', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '15.03', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '17.73', 'groupId': 'OG001'}, {'value': '1.31', 'spread': '20.17', 'groupId': 'OG002'}]}]}, {'title': 'Percent change C3M W24', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '15.29', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '30.10', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '23.88', 'groupId': 'OG002'}]}]}, {'title': 'Percent change C4M W12', 'categories': [{'measurements': [{'value': '1.59', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '-4.82', 'spread': '18.97', 'groupId': 'OG001'}, {'value': '3.19', 'spread': '20.80', 'groupId': 'OG002'}]}]}, {'title': 'Percent change C4M W24', 'categories': [{'measurements': [{'value': '-4.43', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '37.63', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '21.55', 'groupId': 'OG002'}]}]}, {'title': 'Percent change BGM W12', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '14.91', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '18.81', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '23.07', 'groupId': 'OG002'}]}]}, {'title': 'Percent change BGM W24', 'categories': [{'measurements': [{'value': '1.19', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '29.14', 'groupId': 'OG001'}, {'value': '3.77', 'spread': '25.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 12 and 24.', 'description': 'Percent change in serum levels of collagen fragments indicative of collagen formation and degradation, from baseline to Weeks 12 and 24 (serum levels of collagen fragments are measured in ng/mL).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '4.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Absolute change in liver stiffness by subgroup (\\>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24.', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '35.10', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '20.71', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '30.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Percent change in liver stiffness by subgroup (\\>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Pruritis Visual Analogue Scale (VAS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Absolute change W12', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.33', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.79', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change W24', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Absolute Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in Pruritis Visual Analogue Scale (VAS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change W12', 'categories': [{'measurements': [{'value': '-35.1', 'spread': '46.13', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '73.87', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '70.68', 'groupId': 'OG002'}]}]}, {'title': 'Percent change W24', 'categories': [{'measurements': [{'value': '-36.9', 'spread': '58.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '92.71', 'groupId': 'OG001'}, {'value': '27.3', 'spread': '72.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Percent Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Absolute Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Absolute change Symptoms W12', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.19', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '3.52', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Symptoms W24', 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '4.23', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '3.10', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Itch W12', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.79', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Itch W24', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '2.85', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Fatigue W12', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '8.25', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '4.91', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Fatigue W24', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '7.32', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '5.35', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Cognitive W12', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.68', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '4.35', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Cognitive W24', 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '5.34', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '3.67', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Emotional W12', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.35', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Emotional W24', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.78', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Social W12', 'categories': [{'measurements': [{'value': '0.6', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '5.24', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '5.43', 'groupId': 'OG002'}]}]}, {'title': 'Absolute change Social W24', 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '4.93', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '5.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Absolute Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}, {'type': 'SECONDARY', 'title': 'Percent Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'OG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'OG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}], 'classes': [{'title': 'Percent change Symptoms W12', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '24.68', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '24.48', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '37.21', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Symptoms W24', 'categories': [{'measurements': [{'value': '1.1', 'spread': '25.27', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '25.19', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '35.03', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Itch W12', 'categories': [{'measurements': [{'value': '-5.6', 'spread': '62.92', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '43.43', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '48.47', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Itch W24', 'categories': [{'measurements': [{'value': '-11.4', 'spread': '52.75', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '41.83', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '40.62', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Fatigue W12', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '21.11', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '26.51', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '20.45', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Fatigue W24', 'categories': [{'measurements': [{'value': '0.3', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '19.81', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '23.07', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Cognitive W12', 'categories': [{'measurements': [{'value': '6.1', 'spread': '56.79', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '32.14', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '51.28', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Cognitive W24', 'categories': [{'measurements': [{'value': '16.0', 'spread': '62.27', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '40.79', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '46.11', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Emotional W12', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '33.88', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '45.99', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Emotional W24', 'categories': [{'measurements': [{'value': '4.9', 'spread': '54.41', 'groupId': 'OG000'}, {'value': '-16.9', 'spread': '26.85', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '34.49', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Social W12', 'categories': [{'measurements': [{'value': '4.8', 'spread': '24.14', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '21.65', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '40.03', 'groupId': 'OG002'}]}]}, {'title': 'Percent change Social W24', 'categories': [{'measurements': [{'value': '8.1', 'spread': '27.94', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '18.38', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '28.53', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Percent Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed in the Intent to Treat population who have evaluable results'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GKT137831 400mg Twice Daily', 'description': 'GKT137831 400mg twice daily\n\nPatients will self-administer 4 capsules in the morning and 4 capsules in the evening.\n\nGKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.'}, {'id': 'FG001', 'title': 'GKT137831 400mg Once Daily', 'description': 'GKT137831 400mg once daily\n\nPatients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos.\n\nGKT137831: GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.\n\nPlacebo oral capsule: Matching capsules.'}, {'id': 'FG002', 'title': 'Placebo Arm', 'description': 'Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos.\n\nPlacebo oral capsule: Matching capsules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment started Sep 2017-Sep 2018'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'GKT137831 400mg Once Daily', 'description': 'Subjects randomized to the 400 mg OD dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'BG001', 'title': 'GKT137831 400mg Twice Daily', 'description': 'Subjects randomized to the 400 mg BID dose arm self-administered IMP twice daily for 24 weeks: 4 active capsules (AM dose) and 4 active capsules (PM dose)'}, {'id': 'BG002', 'title': 'Placebo Arm', 'description': 'Subjects randomized to the placebo arm self-administered placebo twice daily for 24 weeks: 4 placebo capsules (AM dose) and 4 placebo capsules (PM dose)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '9.04', 'groupId': 'BG001'}, {'value': '56.3', 'spread': '9.19', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '9.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease severity level based on baseline serum GGT', 'classes': [{'title': '<2.5 X ULN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': '>= 2.5 X ULN', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-24', 'size': 2399593, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-10T10:48', 'hasProtocol': True}, {'date': '2019-03-15', 'size': 1406330, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-10T10:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This is a double-blind study: the Sponsor, subjects, investigator staff, persons performing the assessments and data reviewers and statisticians will remain blinded to the identity of the study treatments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a double-blind, randomized, placebo-controlled, multicenter, parallel group phase 2 trial. A total of 102 subjects will be randomized and allocated to placebo or one of the 2 active treatment arms, according to a 1:1:1 randomization ratio, stratified at study entry by disease severity defined as baseline serum gamma glutamyl transferase (GGT) \\< 2.5 x ULN or ≥ 2.5 x ULN). Accordingly, approximately 34 subjects will be allocated to each of the 3 treatment arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2017-06-30', 'resultsFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2017-07-07', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-04', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percent Change in Serum GGT.', 'timeFrame': 'Baseline to week 24 (visit 7)', 'description': 'Percent change in serum GGT from baseline to Week 24 (serum GGT was measured in U/L)'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Serum GGT', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum GGT from baseline to each assessment.'}, {'measure': 'Percent Change in Serum GGT', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in serum GGT from baseline to each assessment (serum GGT was measured in U/L)'}, {'measure': 'Percent Change in Serum ALP', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in serum ALP from baseline to each assessment (serum ALP was measured in U/L).'}, {'measure': 'Absolute Change in Serum ALP', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum ALP from baseline to each assessment.'}, {'measure': 'Absolute Change in Serum Conjugated Bilirubin.', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum conjugated bilirubin from baseline to each assessment.'}, {'measure': 'Percent Change in Serum Conjugated Bilirubin.', 'timeFrame': 'From baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in serum Conjugated bilirubin, from baseline to each assessment (serum conjugated bilirubin is measured in μmol/L).'}, {'measure': 'Absolute Change in Serum Total Bilirubin.', 'timeFrame': 'from baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Absolute change in serum total bilirubin, from baseline to each assessment.'}, {'measure': 'Percent Change in Serum Total Bilirubin.', 'timeFrame': 'from baseline to Weeks 2, 6, 12, 18 and 24', 'description': 'Percent change in Serum Total Bilirubin from baseline to each assessment (serum total bilirubin is measured in μmol/L).'}, {'measure': 'Absolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Absolute change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24.'}, {'measure': 'Percent Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Percent change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa).'}, {'measure': 'Percent Change in Serum Levels of Collagen Fragments Indicative of Collagen Formation and Degradation.', 'timeFrame': 'From baseline to Weeks 12 and 24.', 'description': 'Percent change in serum levels of collagen fragments indicative of collagen formation and degradation, from baseline to Weeks 12 and 24 (serum levels of collagen fragments are measured in ng/mL).'}, {'measure': 'Absolute Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Absolute change in liver stiffness by subgroup (\\>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24.'}, {'measure': 'Percent Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).', 'timeFrame': 'From baseline to Week 24, in patients with values at baseline and Week 24.', 'description': 'Percent change in liver stiffness by subgroup (\\>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa).'}, {'measure': 'Absolute Change in Pruritis Visual Analogue Scale (VAS) Scores', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Absolute Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch.'}, {'measure': 'Percent Change in Pruritis Visual Analogue Scale (VAS) Scores', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Percent Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch.'}, {'measure': 'Absolute Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Absolute Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome.'}, {'measure': 'Percent Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores', 'timeFrame': 'From baseline to Weeks 12 and 24', 'description': 'Percent Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Biliary Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '37183520', 'type': 'DERIVED', 'citation': 'Invernizzi P, Carbone M, Jones D, Levy C, Little N, Wiesel P, Nevens F; study investigators. Setanaxib, a first-in-class selective NADPH oxidase 1/4 inhibitor for primary biliary cholangitis: A randomized, placebo-controlled, phase 2 trial. Liver Int. 2023 Jul;43(7):1507-1522. doi: 10.1111/liv.15596. Epub 2023 May 15.'}, {'pmid': '36809195', 'type': 'DERIVED', 'citation': 'Jones D, Carbone M, Invernizzi P, Little N, Nevens F, Swain MG, Wiesel P, Levy C. Impact of setanaxib on quality of life outcomes in primary biliary cholangitis in a phase 2 randomized controlled trial. Hepatol Commun. 2023 Feb 20;7(3):e0057. doi: 10.1097/HC9.0000000000000057. eCollection 2023 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).', 'detailedDescription': "Primary biliary cholangitis (PBC) is a disease of the liver. It is caused a sustained attack by the body's immune system on the bile ducts (canals) inside the liver. This continuous assault leads to their gradual destruction and eventual disappearance. This results in obstruction to the flow of bile which gets worse with disease progression. Once the bile duct injury has been established, the disease progresses due to ongoing obstruction of bile flow, inflammation and scarring of the liver tissue(fibrosis). The liver eventually fails.\n\nThis research is looking into whether the study drug is better than a dummy drug when given to patients with PBC. This trial will monitor the patients taking part with regular blood tests and ultrasound liver scans before, during, and at the end of the trial. These measures will allow for the ongoing assessment of liver function, and liver stiffness. It is hoped that in patients in whom the study drug is beneficial, the liver function or stiffness may progress at a slower pace, or may even improve during or at the end of the trial. Liver injury, inflammation and fibrosis Participants will be randomly assigned to 1 of 3 treatment groups (active drug once daily, active drug twice daily or placebo). This is a double blinded study so neither the participants nor the staff responsible for their care will know which group they have been assigned to. During the treatment period, participants will take 4 capsules orally at home in the morning and 4 capsules in the evening for 24 weeks.\n\nParticipants will be in the trial for 32 weeks in total (about 8 months) and will attend approximately 8 clinic visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female aged 18 to 80 years, inclusive.\n2. Willing and able to give written informed consent and to comply with the requirements of the study.\n3. PBC diagnosis as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:\n\n * History of elevated ALP levels (\\> ULN) for at least 6 months\n * Positive anti-mitochondrial antibody (AMA) titer or if AMA negative or in low titer (\\< 1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components \\[PDC-E2, 2-oxo-glutaric acid dehydrogenase complex\\])\n * Liver biopsy consistent with PBC (based on historic liver biopsy), including non-suppurative, destructive cholangitis affecting mainly the interlobular and septal bile ducts.\n4. Serum ALP ≥ 1.5 x ULN.\n5. Serum GGT ≥ 1.5 x ULN.\n6. UDCA treatment for at least 6 months and stable dose for at least 3 months prior to Visit 1.\n7. Subjects being treated for pruritus with colestyramine must be on a stable dose of colestyramine for at least 8 weeks prior to baseline/Day 1 (Visit 2). Subjects must be willing and able to take colestyramine at least 2 hours before or after study medication.\n8. Female subjects of childbearing potential must use a highly effective method of contraception to prevent pregnancy for 4 weeks before randomization and must agree to continue strict contraception for 90 days after last administration of investigational medicinal product (IMP). Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use an additional form of adequate contraception as approved by the Investigator. This requirement begins at the time of informed consent and ends 90 days after the last administration of IMP. Male study participants must also not donate sperm from baseline until 90 days after the last administration of IMP.\n\nExclusion Criteria:\n\n1. A positive pregnancy test or breast-feeding for female subjects.\n2. Any hepatic decompensation, defined as a past or current history of hepatic encephalopathy, gastrointestinal tract bleeding due to esophageal varices, or ascites.\n3. International normalized ratio (INR) \\> 1.2 unless subject is on anticoagulant therapy.\n4. ALT \\> 3 x ULN.\n5. Total bilirubin \\> 1 x ULN.\n6. Planned or current plasmapheresis or other extra-corporeal treatments (e.g., molecular adsorbent recirculation system (MARS)) for treatment-refractory pruritus.\n7. History of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥ 15.\n8. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma.\n9. Hepatorenal syndrome (type I or II) or Screening serum creatinine \\> ULN.\n10. Competing etiology for liver disease (e.g., hepatitis C, active hepatitis B, non-alcoholic steatohepatitis (NASH), alcoholic liver disease (ALD), autoimmune hepatitis, primary sclerosing cholangitis, Gilbert's Syndrome).\n11. Subjects receiving prohibited medications within 3 months of Screening (Visit 1) according to the list (a, b and c) provided in Section 6.6.2.\n12. Treatment with any investigational agent within 4 weeks of Visit 1 or 5 half-lives of the investigational medicinal product (whichever is longer).\n13. A history of long QT syndrome.\n14. Evidence of any of the following cardiac conduction abnormalities during the screening period:\n\n * A QTc Fredericia interval \\>450 milliseconds for males and \\>470 milliseconds for females.\n * A second or third degree atrioventricular block not successfully treated with a pacemaker.\n15. History of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, in situ prostate cancer, in situ breast ductal carcinoma, or superficial bladder cancer stage 0).\n16. The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior the Screening Visit (Visit 1), or human immunodeficiency virus (HIV) infection.\n17. A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin \\< 10.0 g/dL (or 6.2 mmol/L).\n18. Any condition which, in the opinion of the Investigator, constitutes a risk or contraindication for the participation of the subject in the study, or which could interfere with the study objectives, conduct, or evaluation."}, 'identificationModule': {'nctId': 'NCT03226067', 'briefTitle': 'Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Calliditas Therapeutics AB'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase', 'orgStudyIdInfo': {'id': 'GSN000300'}, 'secondaryIdInfos': [{'id': '2016-004599-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GKT137831 400mg twice daily', 'description': 'GKT137831 400mg twice daily\n\nPatients will self-administer 4 capsules in the morning and 4 capsules in the evening.', 'interventionNames': ['Drug: GKT137831']}, {'type': 'EXPERIMENTAL', 'label': 'GKT137831 400mg once daily', 'description': 'GKT137831 400mg once daily\n\nPatients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos.', 'interventionNames': ['Drug: GKT137831', 'Drug: Placebo oral capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos.', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'GKT137831', 'type': 'DRUG', 'otherNames': ['setanaxib'], 'description': 'GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.', 'armGroupLabels': ['GKT137831 400mg once daily', 'GKT137831 400mg twice daily']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Matching capsules.', 'armGroupLabels': ['GKT137831 400mg once daily', 'Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura Clinical Trials', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '06520-8019', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Liver and GI Specialist c/o (STAR) LLC', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Hepatology Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Centre', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45440', 'city': 'Beavercreek', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Gastroenterology Inc.', 'geoPoint': {'lat': 39.70923, 'lon': -84.06327}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Center for Liver Diseases', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist University Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'St Lukes Episcopal Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78233', 'city': 'Live Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Clinical Research, PLLC', 'geoPoint': {'lat': 29.56523, 'lon': -98.3364}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Bon Secours Liver Institute of Hampton Roads', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Bon Secours Liver Institute of Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CUB Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'T2N4z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Liver Unit', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'R3E3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'H2X0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Universite de Montreal (CHUM) Centre de Recherche Service d'Hepatologie", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre (MUHC)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Friedrich-Alexander University Erlangen-Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe-University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '53105', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitatsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': 'D-69210', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': 'D-55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Hippocratio"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Laiko General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '41100', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Centre', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '9103102', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '49100', 'city': 'Petach-Tiqva', 'country': 'Israel', 'facility': 'Rabin Medical Centre'}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Centre', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '3906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Tel-Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'University of Milan-Bicocca', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Università Politecnica delle Marche - Facoltà di Medicina e Chirurgia', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Policlinico of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '71013', 'city': 'Foggia', 'country': 'Italy', 'facility': 'San Giovanni Rotondo Hospital (Puglia)', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University Hospital Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Puerta de Hierro-Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28223', 'city': 'Madrid', 'country': 'Spain', 'facility': 'University of Alcalá', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29015', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Virgen De La Victoria University Hospital', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Plymouth Hospital NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Hull and East Yorkshire Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'GL13NN', 'city': 'Gloucester', 'state': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'DD19SY', 'city': 'Dundee', 'state': 'Tayside', 'country': 'United Kingdom', 'facility': 'Tayside Medical Science Centre (TASC)', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'B152GW', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SA28PP', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Singleton Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Philippe Wiesel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Calliditas Therapeutics AB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calliditas Therapeutics AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}