drugset / Trial / NCT05239468
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
Timeline
- Start
- 2022-03-21
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bezafibrate | Small molecule | 100 mg | Oral |
| Subject | Bezafibrate | Small molecule | 400 mg | Oral |
| Subject | Obeticholic Acid | Small molecule | 5 mg | Oral |