977-311
Research type
Research Study
Full title
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
IRAS ID
1010035
Contact name
Ingrid Delaet
Contact email
Sponsor organisation
Intercept Pharmaceuticals, Inc.
Eudract number
2023-507771-22
Research summary
This is a Phase 3, open-label, long-term safety extension (LTSE) study to evaluate the safety, tolerability, and efficacy of Obeticholic acid (OCA) + Bezafibrate (BZF) Fixed-dose combination tablet (FDC), participants with Primary Biliary Cholangitis (PBC). FDC means that both study drugs are combined in one tablet. Each tablet contains a dose of 5 mg OCA + 400 BZF mg. Approximately 133 patients with PBC will take part in the study for up to 60 months (5 years). Only participants who previously had taken part in specific studies are eligible to take part in this new study. The participants from the 747-213 Study or 747-214 study will transition into Study 977-311 once Study 977-311 is active at their respective hospitals. The time subjects have spent in their previous respective studies will not count toward the 60 months in Study 977-311. Participants will transition to this new study and will receive the study drug once daily at the same time. After the Day 1, Month 1, Month 3, and Month 6 visits, subsequent in-clinic study visits will occur every 6 months for the assessment of safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).
REC name
Wales REC 2
REC reference
24/WA/0233
Date of REC Opinion
2 Dec 2024
REC opinion
Further Information Favourable Opinion