A Phase 3 interventional study of FDC tablet (OCA 5 mg + BZF 400 mg SR) in Primary Biliary Cholangitis, sponsored by Intercept Pharmaceuticals. Terminated at 51 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Intercept Pharmaceuticals · Phase 3, Interventional, and Treatment
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).
208 studies on the registry are indexed under Liver Cirrhosis, Biliary; 44 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 150 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Intercept Pharmaceuticals is the lead sponsor of 21 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.
Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)
Participants will be administered with FDC tablets once daily.
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.
Time frame: 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.
Time frame: Early Termination (Up to Month 12)
Number of Participants Reporting All-Cause Mortality
All-cause mortality included all reported deaths of participants during the study due to any cause.
Time frame: Early Termination (Up to Month 12)
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.
Time frame: 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.
Time frame: Early Termination (Up to Month 12)
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.
| Milestone | OCA 5 mg + BZF 400 mg |
|---|---|
| Started | 62 |
| Completed | 0 |
| Not completed | 62 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Sponsor decision | 60 |
| Withdrew: Non-compliance with the protocol | 1 |
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.
| Participants | OCA 5 mg + BZF 400 mg |
|---|---|
| TEAEs | 29 |
| Serious TEAEs | 3 |
| TEAEs leading to discontinuation | 1 |
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.
| participants | OCA 5 mg + BZF 400 mg |
|---|---|
| Number of Participants Reporting Severe TEAEs | 1 |
All-cause mortality included all reported deaths of participants during the study due to any cause.
| Participants | OCA 5 mg + BZF 400 mg |
|---|---|
| Number of Participants Reporting All-Cause Mortality | 0 |
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.
| Participants | OCA 5 mg + BZF 400 mg |
|---|---|
| Basophils (Low) | 0 |
| Basophils (High) | 0 |
| Eosinophils (Low) | 0 |
| Eosinophils (High) | 1 |
| Erythrocyte Mean Corpuscular Hemoglobin Concentration (Low) | 15 |
| Erythrocyte Mean Corpuscular Hemoglobin Concentration (High): | 0 |
| Erythrocyte Mean Corpuscular Hemoglobin (Low) | 4 |
| Erythrocyte Mean Corpuscular Hemoglobin (High) | 0 |
| Erythrocyte Mean Corpuscular Volume (Low) | 0 |
| Erythrocyte Mean Corpuscular Volume (High) | 4 |
| Erythrocytes (Low) | 2 |
| Erythrocytes (High) | 0 |
| Hematocrit (Low) | 0 |
| Hematocrit (High) | 2 |
| Hemoglobin (Low) | 3 |
| Hemoglobin (High) | 0 |
| Leukocytes (Low) | 2 |
| Leukocytes (High) | 0 |
| Lymphocytes (Low) | 3 |
| Lymphocytes (High) | 2 |
| Monocytes (Low) | 0 |
| Monocytes (High) | 0 |
| Neutrophils (Low) | 1 |
| Neutrophils (High) | 0 |
| Platelets (Low) | 2 |
| Platelets (High) | 4 |
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.
| Participants | OCA 5 mg + BZF 400 mg |
|---|---|
| Albumin (Low) | 0 |
| Albumin (High) | 0 |
| Alkaline Phosphatase (Low) | 0 |
| Alkaline Phosphatase (High) | 36 |
| Alanine Aminotransferase (Low) | 0 |
| Alanine Aminotransferase (High) | 9 |
| Amylase (Low) | 1 |
| Amylase (High) | 1 |
| Aspartate Aminotransferase (Low) | 0 |
| Aspartate Aminotransferase (High) | 8 |
| Bicarbonate (Low) | 15 |
| Bicarbonate (High) | 0 |
| Direct Bilirubin (Low) | 0 |
| Direct Bilirubin (High) | 3 |
| Bilirubin (Low) | 0 |
| Bilirubin (High) | 7 |
| Indirect Bilirubin (Low) | 0 |
| Indirect Bilirubin (High) | 0 |
| Calcium (Low) | 0 |
| Calcium (High) | 0 |
| Cholesterol (Low) | 0 |
| Cholesterol (High) | 38 |
| Creatine Kinase (Low) | 0 |
| Creatine Kinase (High) | 0 |
| Chloride (Low) | 0 |
| Chloride (High) | 0 |
| Creatinine (Low) | 8 |
| Creatinine (High) | 0 |
| Free Fatty Acid (Low) | 0 |
| Free Fatty Acid (High) | 2 |
| Glomerular Filtration Rate, Estimated (Low) | 2 |
| Glomerular Filtration Rate, Estimated (High) | 5 |
| Gamma Glutamyl Transferase (Low) | 0 |
| Gamma Glutamyl Transferase (High) | 31 |
| Non-Fasting Glucose (Low) | 0 |
| Non-Fasting Glucose (High) | 13 |
| High Density Cholesterol (Low) | 1 |
| High Density Cholesterol (High) | 0 |
| Hyaluronic Acid (Low) | 0 |
| Hyaluronic Acid (High) | 0 |
| Potassium (Low) | 0 |
| Potassium (High) | 1 |
| Low Density Cholesterol (Low) | 0 |
| Low Density Cholesterol (High) | 37 |
| Lipase (Low) | 0 |
| Lipase (High) | 3 |
| Liver Fibrosis Score (Low) | 0 |
| Liver Fibrosis Score (High) | 12 |
| Magnesium (Low) | 0 |
| Magnesium (High) | 0 |
| Choriogonadotropin Beta (Low) | 0 |
| Choriogonadotropin Beta (High) | 0 |
| Phosphate (Low) | 1 |
| Phosphate (High) | 0 |
| Procollagen 3 N-Terminal Peptide (Low) | 1 |
| Procollagen 3 N-Terminal Peptide (High) | 0 |
| Protein (Low) | 0 |
| Protein (High) | 2 |
| Sodium (Low) | 0 |
| Sodium (High) | 0 |
| Tissue Inhibitor of Matrix Metalloproteinase 1 (Low) | 0 |
| Tissue Inhibitor of Matrix Metalloproteinase 1 (High) | 0 |
| Triglycerides (Low) | 1 |
| Triglycerides (High) | 2 |
| Urea Nitrogen (Low) | 0 |
| Urea Nitrogen (High) | 8 |
| Very Low-Density Lipoprotein Cholesterol (Low) | 1 |
| Very Low-Density Lipoprotein Cholesterol (High) | 1 |
Collected over Early Termination (Up to Month 12). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OCA 5 mg + BZF 400 mg | 0/62 (0%) | 3/62 (4.8%) | 29/62 (46.8%) |
| Event | OCA 5 mg + BZF 400 mg |
|---|---|
| Myocardial infarctionCardiac disorders | 1/62 |
| FallInjury, poisoning and procedural complications | 1/62 |
| Radius fractureInjury, poisoning and procedural complications | 1/62 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/62 |
| Event | OCA 5 mg + BZF 400 mg |
|---|---|
| PruritusSkin and subcutaneous tissue disorders | 5/62 |
| Urinary tract infectionInfections and infestations | 4/62 |
| NasopharyngitisInfections and infestations | 2/62 |
| Soft tissue injuryInjury, poisoning and procedural complications | 2/62 |
| Activated partial thromboplastin time prolongedInvestigations | 2/62 |
| Blood alkaline phosphatase increasedInvestigations | 2/62 |
| FatigueGeneral disorders | 2/62 |
| BronchitisInfections and infestations | 1/62 |
| InfluenzaInfections and infestations | 1/62 |
| SinusitisInfections and infestations | 1/62 |
The LTSE Population included all participants who received at least 1 dose of the FDC tablet.
| Age, Continuous(years) | OCA 5 mg + BZF 400 mg |
|---|---|
| Mean | 55.7 ± 9.93 |
| Sex/Gender, Customized(participants) | OCA 5 mg + BZF 400 mg |
|---|---|
| Male | 5 |
| Female | 54 |
| Unknown | 3 |
| Ethnicity (NIH/OMB)(Participants) | OCA 5 mg + BZF 400 mg |
|---|---|
| Hispanic or Latino | 20 |
| Not Hispanic or Latino | 41 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | OCA 5 mg + BZF 400 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 61 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Intercept Pharmaceuticals