Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-01 @ 4:43 PM
Study NCT ID:
NCT03420768
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2018-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study treatment to 100 days after the last dose of study treatment. (Up to approximately 2 years)', 'eventGroups': [{'id': 'EG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 16, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abulia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (METAVIR Score) as Determined by Liver Biopsy After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.13', 'ciUpperLimit': '17.70', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '0.26', 'ciUpperLimit': '20.23', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders.\n\nActivity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity\n\nFibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Collagen Proportionate Area (CPA) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.68', 'spread': '2.479', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '2.946', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '1.646', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The change from baseline measurement in Collagen Proportionate Area (CPA) is used to asses the effects of treatment compared to placebo.\n\nAssessment of CPA is a method by which the amount (percentage) of collagen in stained tissue sections is analyzed using morphometric image analysis', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With ≥ 1 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The number of participants with ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe Ishak scoring system is used to grade fibrosis in the histology samples. The Ishak system (0 through 6 scale) was developed to grade portal-based liver fibrosis associated with viral hepatitis:\n\n0: No fibrosis\n\n1. Fibrous expansion of some portal areas, with or without short fibrous septa\n2. Fibrous expansion of most portal areas, with or without short fibrous septa\n3. Fibrous expansion of most portal areas with occasional portal to portal bridging\n4. Fibrous expansion of portal areas with marked bridging (portal to portal as well as portal to central)\n5. Marked bridging (portal-portal and/or portal-central) with occasional nodules (incomplete cirrhosis)\n6. Cirrhosis, probable or definite', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (METAVIR Score) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The number of participants with ≥ 2 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders.\n\nActivity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity\n\nFibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The number of participants with ≥ 2 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe Ishak scoring system is used to grade fibrosis in the histology samples. The Ishak system (0 through 6 scale) was developed to grade portal-based liver fibrosis associated with viral hepatitis: 0: No fibrosis\n\n1. Fibrous expansion of some portal areas, with or without short fibrous septa\n2. Fibrous expansion of most portal areas, with or without short fibrous septa\n3. Fibrous expansion of most portal areas with occasional portal to portal bridging\n4. Fibrous expansion of portal areas with marked bridging (portal to portal as well as portal to central)\n5. Marked bridging (portal-portal and/or portal-central) with occasional nodules (incomplete cirrhosis)\n6. Cirrhosis, probable or definite', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With ≥ 15% Decrease From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and day 85', 'description': 'The number of participants with ≥ 15% decrease from baseline in liver stiffness is used to asses the effects of treatment compared to placebo\n\nMagnetic resonance elastography (MRE) is a noninvasive medical imaging technique that quantitatively measures the stiffness of soft tissues by introducing shear waves and imaging their propagation using magnetic resonance imaging (MRI). MRE will be used to quantitate liver stiffness as a surrogate biomarker of liver fibrosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'OG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.162', 'spread': '0.5807', 'groupId': 'OG000'}, {'value': '-0.064', 'spread': '0.7384', 'groupId': 'OG001'}, {'value': '-0.049', 'spread': '0.5801', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 85', 'description': 'Change from baseline in liver stiffness is used to asses the effects of treatment compared to placebo.\n\nMagnetic resonance elastography (MRE) is a noninvasive medical imaging technique that quantitatively measures the stiffness of soft tissues by introducing shear waves and imaging their propagation using magnetic resonance imaging (MRI). MRE will be used to quantitate liver stiffness as a surrogate biomarker of liver fibrosis', 'unitOfMeasure': 'Change in kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Analysis Set: All participants who are randomized to a treatment and receive at least 1 dose of study medication analyzed as per randomized treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'FG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'FG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Per sponsor decision, Part 2 of the study was not initiated. 61 subjects were randomized and treated in Part 1'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BMS-986263 45 mg QW (Once Weekly)', 'description': 'BMS-986263 45 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'BG001', 'title': 'BMS-986263 90 mg QW (Once Weekly)', 'description': 'BMS-986263 90 mg will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'BG002', 'title': 'Placebo QW (Once Weekly)', 'description': 'Placebo will be administered as an IV infusion QW for a total of 12 weeks in adults with advanced hepatic fibrosis due to Hepatitis C (HCV) who have achieved sustained virologic response (SVR)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '7.45', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '8.24', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '6.47', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '7.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-21', 'size': 4785176, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-03T14:53', 'hasProtocol': True}, {'date': '2019-02-19', 'size': 1232832, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-03T14:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2019-12-09', 'completionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2018-01-29', 'dispFirstSubmitQcDate': '2022-02-03', 'resultsFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2018-02-01', 'dispFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-03', 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (METAVIR Score) as Determined by Liver Biopsy After 12 Weeks of Treatment', 'timeFrame': 'Week 12', 'description': 'The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders.\n\nActivity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity\n\nFibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Collagen Proportionate Area (CPA) After 12 Weeks of Treatment', 'timeFrame': 'Baseline and Week 12', 'description': 'The change from baseline measurement in Collagen Proportionate Area (CPA) is used to asses the effects of treatment compared to placebo.\n\nAssessment of CPA is a method by which the amount (percentage) of collagen in stained tissue sections is analyzed using morphometric image analysis'}, {'measure': 'The Number of Participants With ≥ 1 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment', 'timeFrame': 'Week 12', 'description': 'The number of participants with ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe Ishak scoring system is used to grade fibrosis in the histology samples. The Ishak system (0 through 6 scale) was developed to grade portal-based liver fibrosis associated with viral hepatitis:\n\n0: No fibrosis\n\n1. Fibrous expansion of some portal areas, with or without short fibrous septa\n2. Fibrous expansion of most portal areas, with or without short fibrous septa\n3. Fibrous expansion of most portal areas with occasional portal to portal bridging\n4. Fibrous expansion of portal areas with marked bridging (portal to portal as well as portal to central)\n5. Marked bridging (portal-portal and/or portal-central) with occasional nodules (incomplete cirrhosis)\n6. Cirrhosis, probable or definite'}, {'measure': 'The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (METAVIR Score) After 12 Weeks of Treatment', 'timeFrame': 'Week 12', 'description': 'The number of participants with ≥ 2 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders.\n\nActivity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity\n\nFibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis'}, {'measure': 'The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment', 'timeFrame': 'Week 12', 'description': 'The number of participants with ≥ 2 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo.\n\nThe Ishak scoring system is used to grade fibrosis in the histology samples. The Ishak system (0 through 6 scale) was developed to grade portal-based liver fibrosis associated with viral hepatitis: 0: No fibrosis\n\n1. Fibrous expansion of some portal areas, with or without short fibrous septa\n2. Fibrous expansion of most portal areas, with or without short fibrous septa\n3. Fibrous expansion of most portal areas with occasional portal to portal bridging\n4. Fibrous expansion of portal areas with marked bridging (portal to portal as well as portal to central)\n5. Marked bridging (portal-portal and/or portal-central) with occasional nodules (incomplete cirrhosis)\n6. Cirrhosis, probable or definite'}, {'measure': 'The Number of Participants With ≥ 15% Decrease From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) at Day 85', 'timeFrame': 'Baseline and day 85', 'description': 'The number of participants with ≥ 15% decrease from baseline in liver stiffness is used to asses the effects of treatment compared to placebo\n\nMagnetic resonance elastography (MRE) is a noninvasive medical imaging technique that quantitatively measures the stiffness of soft tissues by introducing shear waves and imaging their propagation using magnetic resonance imaging (MRI). MRE will be used to quantitate liver stiffness as a surrogate biomarker of liver fibrosis.'}, {'measure': 'Change From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) Day 85', 'timeFrame': 'Baseline and day 85', 'description': 'Change from baseline in liver stiffness is used to asses the effects of treatment compared to placebo.\n\nMagnetic resonance elastography (MRE) is a noninvasive medical imaging technique that quantitatively measures the stiffness of soft tissues by introducing shear waves and imaging their propagation using magnetic resonance imaging (MRI). MRE will be used to quantitate liver stiffness as a surrogate biomarker of liver fibrosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Cirrhosis', 'Liver Fibrosis']}, 'referencesModule': {'references': [{'pmid': '34605045', 'type': 'DERIVED', 'citation': 'Lawitz EJ, Shevell DE, Tirucherai GS, Du S, Chen W, Kavita U, Coste A, Poordad F, Karsdal M, Nielsen M, Goodman Z, Charles ED. BMS-986263 in patients with advanced hepatic fibrosis: 36-week results from a randomized, placebo-controlled phase 2 trial. Hepatology. 2022 Apr;75(4):912-923. doi: 10.1002/hep.32181. Epub 2021 Dec 13.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n* Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\nExclusion Criteria:\n\n* Other causes of liver disease (eg, alcoholic liver disease, HBV \\[serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results\\], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n* Participants having liver diseases associated with infection with any other hepatitis virus\n* Detectable HCV RNA at screening\n* Child-Pugh score \\> 6\n* Model for End-Stage Liver Disease score \\>12\n* Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP \\> 100 ng/mL (\\> 82.6 IU/mL) OR AFP ≥ 50 and ≤ 100 ng/mL (≥ 41.3 IU/mL and ≤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging \\[MRI\\] or computed tomography; based on local assessment), or ultrasound\n* Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n* Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03420768', 'briefTitle': 'A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C', 'orgStudyIdInfo': {'id': 'IM025-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 BMS-986263 45mg weekly', 'interventionNames': ['Drug: BMS-986263']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 BMS-986263 90mg weekly', 'interventionNames': ['Drug: BMS-986263']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 Placebo weekly', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 BMS-986263 45mg every 2 weeks', 'interventionNames': ['Drug: BMS-986263']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 BMS-986263 90mg every 2 weeks', 'interventionNames': ['Drug: BMS-986263']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 BMS-986263 90mg every 4 weeks', 'interventionNames': ['Drug: BMS-986263']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 Placebo every 2 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'BMS-986263', 'type': 'DRUG', 'description': 'Administered by intravenous (IV) infusion', 'armGroupLabels': ['Part 1 BMS-986263 45mg weekly', 'Part 1 BMS-986263 90mg weekly', 'Part 2 BMS-986263 45mg every 2 weeks', 'Part 2 BMS-986263 90mg every 2 weeks', 'Part 2 BMS-986263 90mg every 4 weeks']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered by intravenous (IV) infusion', 'armGroupLabels': ['Part 1 Placebo weekly', 'Part 2 Placebo every 2 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}