Clinical trial

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

Name

977-311

Description

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).

Trial arms

Trial start

2024-07-01

Estimated PCD

2025-01-01

Trial end

2030-03-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

FDC tablet (OCA 5 mg + BZF 400 mg SR)

Participants will be administered with FDC tablets once daily.

Arms:

OCA 5 mg + BZF 400 mg SR

Size

133

Primary endpoint

Number of participants reporting adverse events (AE) and serious adverse event (SAE)

Up to 60 months

Eligibility criteria

Inclusion Criteria: * All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311). Exclusion Criteria: * History or presence of other concomitant liver diseases * Clinical complications of PBC * History or presence of hepatic decompensating events * Current or history of gallbladder disease * If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 133, 'type': 'ESTIMATED'}}

Updated at

2024-07-04

1 organization

1 product

1 indication

Organization

Intercept Pharmaceuticals

Product

OCA + BZF

Indication

Primary Biliary Cholangitis