drugset / Trial / NCT06488911
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
NaSingle-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2024-07-01
- Primary completion
- 2025-10-21
- Completion
- 2025-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bezafibrate | Small molecule | 400 mg | — |
| Subject | Obeticholic Acid | Small molecule | 5 mg | — |