drugset / Trial / NCT04594694
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
Timeline
- Start
- 2019-10-02
- Primary completion
- 2025-10-14
- Completion
- 2025-10-14
Publications
- Background Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
- Background European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bezafibrate | Small molecule | 200 mg | — |
| Subject | Bezafibrate | Small molecule | 400 mg | — |
| Subject | Obeticholic Acid | Small molecule | 10 mg | — |