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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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An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCA 5 mg + BZF 400 mg SR | Experimental | Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC tablet (OCA 5 mg + BZF 400 mg SR) | Drug | Participants will be administered with FDC tablets once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation | A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention. | Early Termination (Up to Month 12) |
| Number of Participants Reporting Severe TEAEs | A severe (Grade 3) TEAE is defined as an AE that causes inability to carry out usual activities; the subject may experience intolerable discomfort or pain. | Early Termination (Up to Month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting All-Cause Mortality | All-cause mortality included all reported deaths of participants during the study due to any cause. | Early Termination (Up to Month 12) |
| Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters |
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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, PhD | Intercept Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Southern California Research Center |
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62 total participants were enrolled.
This was a Phase 3, open-label, long-term safety extension (LTSE) that evaluated the safety and tolerability of the fixed-dose combination (FDC) of obeticholic acid (OCA) and bezafibrate (BZF) in participants with primary biliary cholangitis (PBD) for up to 60 months. All participants from Studies 747-213 (NCT04594694) or 747-214 (NCT05239468) who met respective protocol requirements were transitioned into Study 977-311 at their respective sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | OCA 5 mg + BZF 400 mg | Participants received FDC tablet (OCA 5mg [milligrams] + BZF 400 mg sustained release [SR]) once daily (QD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2024 | May 12, 2026 |
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Clinically notable shift from baseline in blood hematology parameters data was presented for low and high numbers of participants at early termination visit (up to Month 12). The number of participants with clinically notable shift from baseline was presented. |
| Early Termination (Up to Month 12) |
| Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters | Clinically notable shift from baseline in blood serum chemistry data were presented for low and high numbers of participants at early termination visit (up to Month 12). Change from baseline was calculated as post baseline value minus baseline value. Baseline was defined as the last assessment performed before the first dose of investigational product in Study 977-311. | Early Termination (Up to Month 12) |
| Coronado |
| California |
| 92118 |
| United States |
| Tampa General Medical Group | Tampa | Florida | 33606 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| East Tennessee Research Institute | Johnson City | Tennessee | 37604 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| American Research Corporation | San Antonio | Texas | 78215 | United States |
| DIM Clinica Privada | Buenos Aires | Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
| Hospital Italiano de La Plata | Buenos Aires | Argentina |
| Hospital Universitario Austral | Buenos Aires | Argentina |
| Hospital Provincial del Centenario | Santa Fe | Argentina |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | 5042 | Australia |
| UZ Leuven | Leuven | 3000 | Belgium |
| University of Alberta Division of Gastroenterology Zeidler Ledcor Centre | Edmonton | Alberta | Canada |
| Pacific Gastroenterology Associates GI Research Institute | Vancouver | British Columbia | Canada |
| Universityl Hospital Dubrava | Zagreb | 10 000 | Croatia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 50012 | Czechia |
| Artroscan s.r.o. Gastroenterologicka | Ostrava | 722100 | Czechia |
| Research Site SRO | Pilsen | 30100 | Czechia |
| Tartu University Hospital | Tartu | 50090 | Estonia |
| Hopital Henri Mondor | Créteil | 94000 | France |
| CHRU de Lille | Lille | 59000 | France |
| CHU Paris Est - Hopital Saint Antoine | Paris | 75012 | France |
| Hopital de la Pitie Salpetriere | Paris | 75013 | France |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| University Hospital of Larissa | Larissa | 41110 | Greece |
| DEOEC II. sz. Belgygyszati Klinika | Debrecen | 4032 | Hungary |
| Hadassah Ein-Karem Medical Center - Liver unit | Jerusalem | 9112001 | Israel |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi | Bologna | Italy |
| University Hopital Santaros klinikos | Vilnius | 8661 | Lithuania |
| Academisch Medisch Centrum | Amsterdam | 1005 AZ | Netherlands |
| Akershus University Hospital | Lørenskog | 1478 | Norway |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Hospital ClinicUniversity of Barcelona | Barcelona | 8036 | Spain |
| Consorcio Hospital General Universitario | Valencia | 46014 | Spain |
| Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology | Ankara | Turkey (Türkiye) |
| Ege University, Faculty of Medicine, Gastroenterology | Bornova | Turkey (Türkiye) |
| Istanbul University, Capa Faculty of Medicine, Gastroenterology | Istanbul | Turkey (Türkiye) |
| Harran University Hospital, Gastroenterology | Sanliurfa | Turkey (Türkiye) |
| Hull University Teaching Hospitals NHS Trust | Hull | HU32JZ | United Kingdom |
| Institute of Cellular Medicine Newcastle University | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
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The LTSE Population included all participants who received at least 1 dose of the FDC tablet.
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| ID | Title | Description |
|---|---|---|
| BG000 | OCA 5 mg + BZF 400 mg | Participants received FDC tablet [OCA 5mg + BZF 400 mg SR] QD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation | A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention. | LTSE Population | Posted | Count of Participants | Participants | Early Termination (Up to Month 12) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Severe TEAEs | A severe (Grade 3) TEAE is defined as an AE that causes inability to carry out usual activities; the subject may experience intolerable discomfort or pain. | LTSE Population | Posted | Number | participants | Early Termination (Up to Month 12) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting All-Cause Mortality | All-cause mortality included all reported deaths of participants during the study due to any cause. | LTSE Population | Posted | Count of Participants | Participants | Early Termination (Up to Month 12) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters | Clinically notable shift from baseline in blood hematology parameters data was presented for low and high numbers of participants at early termination visit (up to Month 12). The number of participants with clinically notable shift from baseline was presented. | LTSE Population. Only those participants with data available at specified time points have been presented. | Posted | Count of Participants | Participants | Early Termination (Up to Month 12) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters | Clinically notable shift from baseline in blood serum chemistry data were presented for low and high numbers of participants at early termination visit (up to Month 12). Change from baseline was calculated as post baseline value minus baseline value. Baseline was defined as the last assessment performed before the first dose of investigational product in Study 977-311. | LTSE Population. Only those participants with data available at specified time points have been presented. | Posted | Count of Participants | Participants | Early Termination (Up to Month 12) |
|
|
Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCA 5 mg + BZF 400 mg | Participants received FDC tablet [OCA 5mg + BZF 400 mg SR] QD. | 0 | 62 | 3 | 62 | 29 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (28.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (28.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Testicular retraction | Reproductive system and breast disorders | MedDRA (28.0) | Non-systematic Assessment |
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| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (28.0) | Non-systematic Assessment |
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The Sponsor 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Intercept Pharmaceuticals, Inc. | 844-782-4278 | medinfo@interceptpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2025 | May 12, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| 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 |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories |
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