Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT03890120
Status:
TERMINATED
Last Update Posted:
2023-11-29
First Post:
2019-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717094', 'term': 'cilofexor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days', 'description': 'All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study.\n\nAdverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.', 'otherNumAtRisk': 277, 'deathsNumAtRisk': 278, 'otherNumAffected': 232, 'seriousNumAtRisk': 277, 'deathsNumAffected': 2, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 141, 'otherNumAffected': 109, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Cilofexor From Cilofexor 100 mg (OLE Phase)', 'description': 'Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 34, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Cilofexor From Placebo (OLE Phase)', 'description': 'Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 24, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 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(25.1)'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cholangitis sclerosing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Colorectostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Ligament operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Liver transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '32.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-15.2', 'ciUpperLimit': '12.3', 'estimateComment': 'The difference of cilofexor and placebo,95% confidence interval(CI),and P value(1-sided)were obtained by the stratum-adjusted Mantel-Haenszel (MH) method,with baseline ursodeoxycholic acid(UDCA)use and Ludwig fibrosis stage as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Blinded Phase Week 96', 'description': 'Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants in the Full Analysis Set who had nonmissing data at both baseline and Week 96 in the Blinded Study Phase were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000'}, {'value': '95.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date in the Blinded Phase up to 100.3 weeks plus 30 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced TEAEs in The OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor From Cilofexor 100 mg (OLE Phase)', 'description': 'Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.'}, {'id': 'OG001', 'title': 'Cilofexor From Placebo (OLE Phase)', 'description': 'Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date in the OLE Phase up to 45 weeks plus 30 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date in the Blinded Phase up to 100.3 weeks plus 30 days', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor From Cilofexor 100 mg (OLE Phase)', 'description': 'Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.'}, {'id': 'OG001', 'title': 'Cilofexor From Placebo (OLE Phase)', 'description': 'Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date in the OLE Phase up to 45 weeks plus 30 days', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the OLE Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '16'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-19', 'upperLimit': '25'}]}]}], 'analyses': [{'pValue': '0.3884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Mean (LSM)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4', 'ciLowerLimit': '-28', 'ciUpperLimit': '21', 'estimateComment': 'The LSM,95% CI and P-value(1-sided) were obtained by an analysis of covariance(ANCOVA)model with change at Week 96 as dependent variable,baseline value of outcome measure,baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '-6'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-12', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.0390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-20', 'ciUpperLimit': '1', 'estimateComment': 'The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'unitOfMeasure': 'U/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '13.5'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '17.9'}]}]}], 'analyses': [{'pValue': '0.2845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '6.4', 'estimateComment': 'The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'unitOfMeasure': 'micromoles per liter (μmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1978', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '13.5', 'estimateComment': 'The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': 'The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with ≥ 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '21.2', 'estimateComment': 'The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Blinded Phase Week 96', 'description': 'Fibrosis improvement was defined as having ≥ 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '11', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '0', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-1', 'ciUpperLimit': '3', 'estimateComment': 'The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': 'The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.38'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.45'}]}]}], 'analyses': [{'pValue': '0.3636', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.14', 'estimateComment': 'The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': 'The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '3.6'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '4.4'}]}]}], 'analyses': [{'pValue': '0.3595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.5', 'estimateComment': 'The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': "Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s).", 'unitOfMeasure': 'kilopascals (kPa)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'FG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.'}, {'id': 'FG002', 'title': 'Cilofexor From Cilofexor 100 mg (OLE Phase)', 'description': 'Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.'}, {'id': 'FG003', 'title': 'Cilofexor From Placebo (OLE Phase)', 'description': 'Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.'}], 'periods': [{'title': 'Blinded Treatment Phase (100.3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Investigator's discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Extension Phase (45 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who consented to enter the OLE Phase and completed the Blinded Study Phase Week 96 with an evaluable biopsy (noncirrhotic F0, F1, F2, and F3) as determined by the central reader and Blinded Study Phase follow-up visit entered OLE Phase.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who consented to enter the OLE Phase and completed the Blinded Study Phase Week 96 with an evaluable biopsy (noncirrhotic F0, F1, F2, and F3) as determined by the central reader and Blinded Study Phase follow-up visit entered OLE Phase.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants who consented to enter the OLE Phase and completed the Blinded Study Phase Week 96 with an evaluable biopsy (noncirrhotic F0, F1, F2, and F3) as determined by the central reader and Blinded Study Phase follow-up visit entered OLE Phase.', 'groupId': 'FG002', 'numSubjects': '80'}, {'comment': 'Participants who consented to enter the OLE Phase and completed the Blinded Study Phase Week 96 with an evaluable biopsy (noncirrhotic F0, F1, F2, and F3) as determined by the central reader and Blinded Study Phase follow-up visit entered OLE Phase.', 'groupId': 'FG003', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Europe, North America, Oceania, and Asia.', 'preAssignmentDetails': '587 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.'}, {'id': 'BG001', 'title': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '44', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '44', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Other or More Than One Race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alkaline Phosphatase (ALP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '223', 'spread': '177.7', 'groupId': 'BG000'}, {'value': '243', 'spread': '189.5', 'groupId': 'BG001'}, {'value': '230', 'spread': '181.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate Aminotransferase (AST)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'spread': '34.1', 'groupId': 'BG000'}, {'value': '51', 'spread': '34.6', 'groupId': 'BG001'}, {'value': '50', 'spread': '34.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Total Bile Acids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.2', 'spread': '37.57', 'groupId': 'BG000'}, {'value': '18.6', 'spread': '22.49', 'groupId': 'BG001'}, {'value': '22.4', 'spread': '33.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micromoles per liter (μmol/L)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'title': 'Enhanced Liver Fibrosis (ELF™) Test Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.14', 'spread': '0.910', 'groupId': 'BG000'}, {'value': '9.13', 'spread': '0.963', 'groupId': 'BG001'}, {'value': '9.13', 'spread': '0.927', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'title': 'Fibroscan Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '4.91', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '4.07', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '4.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver.", 'unitOfMeasure': 'kilopascals (kPa)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in the safety analysis set with available data were analyzed.'}], 'populationDescription': 'Safety Analysis Set included all participants who took at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-16', 'size': 27509850, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-05T08:43', 'hasProtocol': True}, {'date': '2022-08-10', 'size': 29457138, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-26T11:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 419}}, 'statusModule': {'whyStopped': 'Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2019-03-25', 'resultsFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-06', 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96', 'timeFrame': 'Blinded Phase Week 96', 'description': 'Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase', 'timeFrame': 'First dose date in the Blinded Phase up to 100.3 weeks plus 30 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.'}, {'measure': 'Percentage of Participants Who Experienced TEAEs in The OLE Phase', 'timeFrame': 'First dose date in the OLE Phase up to 45 weeks plus 30 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.'}, {'measure': 'Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase', 'timeFrame': 'First dose date in the Blinded Phase up to 100.3 weeks plus 30 days', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.'}, {'measure': 'Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase', 'timeFrame': 'First dose date in the OLE Phase up to 45 weeks plus 30 days', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.'}, {'measure': 'Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96'}, {'measure': 'Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96'}, {'measure': 'Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96'}, {'measure': 'Percentage of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': 'The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with ≥ 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed.'}, {'measure': 'Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96', 'timeFrame': 'Blinded Phase Week 96', 'description': 'Fibrosis improvement was defined as having ≥ 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).'}, {'measure': 'Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': 'The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms.'}, {'measure': 'Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': 'The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis.'}, {'measure': 'Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96', 'timeFrame': 'Baseline, Blinded Phase Week 96', 'description': "Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Sclerosing Cholangitis']}, 'referencesModule': {'references': [{'pmid': '36922785', 'type': 'BACKGROUND', 'citation': 'Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2.'}, {'type': 'BACKGROUND', 'citation': 'Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13.'}, {'pmid': '41173015', 'type': 'DERIVED', 'citation': 'Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, Joshi D, Salminen K, Yimam K, Isayama H, Montano-Loza AJ, Caldwell S, Danta M, Farkkila M, Gallegos-Orozco JF, Gordon SC, Hinrichsen H, Invernizzi P, Vuppalanchi R, Zhu K, Xu J, Liu X, Lu X, Crans G, Bolbolan S, Boyette L, Alani M, Barchuk WT, Watkins TR, Genovese MC, Bowlus CL. Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2025 Oct 28:S2468-1253(25)00208-0. doi: 10.1016/S2468-1253(25)00208-0. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT03890120', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Diagnosis of large duct PSC\n* Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader\n* Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:\n\n * Platelet count ≥ 150,000/mm\\^3\n * Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation\n * Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)\n * Total bilirubin \\< 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia\n * International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation\n * Negative anti-mitochondrial antibody\n\nKey Exclusion Criteria:\n\n* Current or prior history of any of the following:\n\n * Cirrhosis\n * Liver transplantation\n * Cholangiocarcinoma or hepatocellular carcinoma (HCC)\n * Ascending cholangitis within 30 days of screening\n* Presence of a percutaneous drain or biliary stent\n* Other causes of liver disease\n* Current or prior history of unstable cardiovascular disease\n* Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT03890120', 'acronym': 'PRIMIS', 'briefTitle': 'Study of Cilofexor in Adults With Primary Sclerosing Cholangitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis', 'orgStudyIdInfo': {'id': 'GS-US-428-4194'}, 'secondaryIdInfos': [{'id': '2019-000204-14', 'type': 'EUDRACT_NUMBER'}, {'id': 'jRCT2080224728', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cilofexor 100 mg (Blinded Phase)', 'description': 'Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.', 'interventionNames': ['Drug: Cilofexor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Blinded Phase)', 'description': 'Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cilofexor From Cilofexor 100 mg (OLE Phase)', 'description': 'Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.', 'interventionNames': ['Drug: Cilofexor']}, {'type': 'EXPERIMENTAL', 'label': 'Cilofexor From Placebo (OLE Phase)', 'description': 'Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.', 'interventionNames': ['Drug: Cilofexor']}], 'interventions': [{'name': 'Cilofexor', 'type': 'DRUG', 'otherNames': ['GS-9674'], 'description': '100 mg tablet administered orally once daily', 'armGroupLabels': ['Cilofexor 100 mg (Blinded Phase)', 'Cilofexor From Cilofexor 100 mg (OLE Phase)', 'Cilofexor From Placebo (OLE Phase)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet administered orally once daily', 'armGroupLabels': ['Placebo (Blinded Phase)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Institute For Liver Health', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Heath', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Altman Clinical and Translational Research Institute (Clinic)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic/Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ruane Clinical Research Group Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94025', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Liver Research Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center (study visits)', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Pacific Medical Foundation - California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco Liver Clinic', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90048', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver and Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Peak Gastroenterology Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80113', 'city': 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'country': 'United States', 'facility': 'Advanced Medical Research Center', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Atlanta Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital; Clinical Research Unit', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center 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'21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NECCR PrimaCare Research, LLC', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 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