Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-30 @ 9:32 AM
Study NCT ID:
NCT04594694
Status:
TERMINATED
Last Update Posted:
2025-11-17
First Post:
2020-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Ireland', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C464660', 'term': 'obeticholic acid'}, {'id': 'D001629', 'term': 'Bezafibrate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, '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': 75}}, 'statusModule': {'whyStopped': "Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the DB Treatment Period', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}], 'secondaryOutcomes': [{'measure': 'Response rates of ≥10%, ≥20%, ≥30% and ≥40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP)', 'timeFrame': 'Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12'}, {'measure': 'Number of participants with normalization rates of biochemical disease marker Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), total and conjugated bilirubin and lipid panel', 'timeFrame': 'Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12'}, {'measure': 'Change in GGT from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}, {'measure': 'Change in ALT from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}, {'measure': 'Change in AST from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}, {'measure': 'Change in total and conjugated bilirubin from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}, {'measure': 'Change in lipid panel from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}, {'measure': 'Change in 7 alpha (α) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4, 8, and 12'}, {'measure': 'Change in bile acid from baseline to Week 12', 'timeFrame': 'Baseline, Day 1, and Weeks 4,8, and 12'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Biliary Cholangitis', 'Primary Biliary Cirrhosis', 'PBC', 'Hepatic Impairment', 'Cirrhosis', 'Liver'], 'conditions': ['Primary Biliary Cholangitis']}, 'referencesModule': {'references': [{'pmid': '19554543', 'type': 'BACKGROUND', 'citation': 'Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.'}, {'pmid': '19501929', 'type': 'BACKGROUND', 'citation': 'European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A definite or probable diagnosis of PBC\n* Qualifying ALP and/or bilirubin liver biochemistry values\n* Taking Ursodeoxycholic Acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases\n* Clinical complications of PBC\n* History or presence of hepatic decompensating events\n* Current or history of gallbladder disease\n* If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating\n* Treatment with commercially available OCA or other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04594694', 'briefTitle': 'Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercept Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid', 'orgStudyIdInfo': {'id': '747-213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A: BZF 200 milligrams (mg) Immediate release (IR)', 'description': 'Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo', 'interventionNames': ['Drug: Bezafibrate 200 MG', 'Drug: OCA Placebo', 'Drug: Bezafibrate 400 mg Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B: BZF 400 mg SR', 'description': 'Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo', 'interventionNames': ['Drug: OCA Placebo', 'Drug: Bezafibrate 200 mg Placebo', 'Drug: Bezafibrate 400 MG']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR', 'description': 'Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo', 'interventionNames': ['Drug: Obeticholic acid', 'Drug: Bezafibrate 200 MG', 'Drug: Bezafibrate 400 mg Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR', 'description': 'Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo', 'interventionNames': ['Drug: Obeticholic acid', 'Drug: Bezafibrate 200 mg Placebo', 'Drug: Bezafibrate 400 MG']}, {'type': 'EXPERIMENTAL', 'label': 'Long-term safety extension (LTSE) phase: OCA + BZF', 'description': 'Participants will continue the original treatment assignment allocated during the DB Period. The OCA and BZF dose may be optimized based on safety and efficacy during the DB period.', 'interventionNames': ['Drug: OCA', 'Drug: Bezafibrate']}], 'interventions': [{'name': 'Obeticholic acid', 'type': 'DRUG', 'description': '5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily', 'armGroupLabels': ['Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR', 'Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR']}, {'name': 'Bezafibrate 200 MG', 'type': 'DRUG', 'description': '200 mg IR tablet of Bezafibrate once daily for the remainder of the study', 'armGroupLabels': ['Treatment A: BZF 200 milligrams (mg) Immediate release (IR)', 'Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR']}, {'name': 'OCA Placebo', 'type': 'DRUG', 'description': 'One tablet daily for the remainder of the study', 'armGroupLabels': ['Treatment A: BZF 200 milligrams (mg) Immediate release (IR)', 'Treatment B: BZF 400 mg SR']}, {'name': 'Bezafibrate 200 mg Placebo', 'type': 'DRUG', 'description': 'One tablet daily for the remainder of the study', 'armGroupLabels': ['Treatment B: BZF 400 mg SR', 'Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR']}, {'name': 'Bezafibrate 400 MG', 'type': 'DRUG', 'description': '400 mg SR tablet of Bezafibrate once daily for the remainder of the study', 'armGroupLabels': ['Treatment B: BZF 400 mg SR', 'Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR']}, {'name': 'Bezafibrate 400 mg Placebo', 'type': 'DRUG', 'description': 'One tablet daily for the remainder of the study', 'armGroupLabels': ['Treatment A: BZF 200 milligrams (mg) Immediate release (IR)', 'Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR']}, {'name': 'OCA', 'type': 'DRUG', 'description': 'OCA one tablet will be administered.', 'armGroupLabels': ['Long-term safety extension (LTSE) phase: OCA + BZF']}, {'name': 'Bezafibrate', 'type': 'DRUG', 'description': 'Bezafibrate one tablet will be administered.', 'armGroupLabels': ['Long-term safety extension (LTSE) phase: OCA + BZF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5042', 'city': 'Bedford Park', 'state': 'Perth', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Clinical Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Zagreb University Hospital Center', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '500 12', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Hepato-Gastroenterologie HK, s.r.o.', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '722 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Artroscan s.r.o., Gastroenterologicka ambulance', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '301 00', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Research Site s.r.o.', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '940000', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'Paris 12', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Paris Est - Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitatsklinikum Hamburg-Eppendorf UKE', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '41110', 'city': 'Larissa', 'country': 'Greece', 'facility': 'Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '1111', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Budai Hepatologiai Centrum (BHC)', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'DEOEC II. sz. Belgyógyászati Klinika', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Ein-Karem Medical Center - Liver unit', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Surasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '50161', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian University of Health Sciences, Kauno Klinikos', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vlinius University', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1478', 'city': 'Loerenskog', 'country': 'Norway', 'facility': 'Universitetet i Oslo - Akershus Universitetssykehus (AHUS)'}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '602-739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Fundacio Clinic Per La Recerca Biomedica', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Consorcio Hospital General Universitario', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'NE2 4HH', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Institute of Cellular Medicine, Newcastle University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Lynda Szczech', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intercept Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercept Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}