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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.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BZF 200 milligrams (mg) Immediate release (IR) | Active Comparator | Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo |
|
| Treatment B: BZF 400 mg SR | Active Comparator | Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo |
|
| Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR | Experimental | Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo |
|
| Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR | Experimental | Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo |
|
| Long-term safety extension (LTSE) phase: OCA + BZF | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obeticholic acid | Drug | 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the DB Treatment Period | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rates of ≥10%, ≥20%, ≥30% and ≥40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP) | Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Lynda Szczech | Intercept Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre | Bedford Park | Perth | 5042 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19554543 | Background | 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. | |
| 19501929 | Background | 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. |
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|
| Bezafibrate 200 MG | Drug | 200 mg IR tablet of Bezafibrate once daily for the remainder of the study |
|
| OCA Placebo | Drug | One tablet daily for the remainder of the study |
|
| Bezafibrate 200 mg Placebo | Drug | One tablet daily for the remainder of the study |
|
| Bezafibrate 400 MG | Drug | 400 mg SR tablet of Bezafibrate once daily for the remainder of the study |
|
| Bezafibrate 400 mg Placebo | Drug | One tablet daily for the remainder of the study |
|
| OCA | Drug | OCA one tablet will be administered. |
|
| Bezafibrate | Drug | Bezafibrate one tablet will be administered. |
|
| Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 |
| Change in GGT from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in ALT from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in AST from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in total and conjugated bilirubin from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in lipid panel from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in 7 alpha (α) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in bile acid from baseline to Week 12 | Baseline, Day 1, and Weeks 4,8, and 12 |
| Adelaide |
| 5000 |
| Australia |
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| Clinical Hospital Dubrava | Zagreb | 10000 | Croatia |
| Zagreb University Hospital Center | Zagreb | 10000 | Croatia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 500 12 | Czechia |
| Artroscan s.r.o., Gastroenterologicka ambulance | Ostrava | 722 00 | Czechia |
| Research Site s.r.o. | Pilsen | 301 00 | Czechia |
| Tartu University Hospital | Tartu | 51014 | Estonia |
| Hôpital Henri Mondor | Créteil | 940000 | France |
| Centre Hospitalier Universitaire Grenoble | Grenoble | 38043 | France |
| CHRU de Lille | Lille | 59000 | France |
| Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris | Paris | 75651 | France |
| CHU Paris Est - Hopital Saint Antoine | Paris | Paris 12 | France |
| Universitatsklinikum Hamburg-Eppendorf UKE | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa | Larissa | 41110 | Greece |
| Budai Hepatologiai Centrum (BHC) | Budapest | 1111 | Hungary |
| DEOEC II. sz. Belgyógyászati Klinika | Debrecen | 4032 | Hungary |
| Hadassah Ein-Karem Medical Center - Liver unit | Jerusalem | 91120 | Israel |
| Tel Aviv Surasky Medical Center | Tel Aviv | 6423906 | Israel |
| Hospital of Lithuanian University of Health Sciences, Kauno Klinikos | Kaunas | 50161 | Lithuania |
| Vlinius University | Vilnius | 08661 | Lithuania |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Universitetet i Oslo - Akershus Universitetssykehus (AHUS) | Loerenskog | 1478 | Norway |
| Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej | Warsaw | 02-781 | Poland |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Fundacio Clinic Per La Recerca Biomedica | Barcelona | 08036 | Spain |
| Consorcio Hospital General Universitario | Valencia | 46010 | Spain |
| Hull University Teaching Hospitals NHS Trust | Hull | HU3 2JZ | United Kingdom |
| Institute of Cellular Medicine, Newcastle University | Newcastle upon Tyne | NE2 4HH | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C464660 | obeticholic acid |
| D001629 | Bezafibrate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002723 | Chlorobenzoates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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