Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
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
Outcome
Mixed primary results
Stopped (Business): “Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.”
registry analysis (superiority test); Placebo + BZF 200 mg IR vs OCA 5 mg + BZF 200 mg IR; p = 0.869; Least square mean difference -2.6 (95% CI -34.2 to 28.9) NCT04594694 ↗
registry analysis (superiority test); Placebo + BZF 400 mg SR vs OCA 5 mg + BZF 400 mg SR; p = 0.043; Least square mean difference -46.9 (95% CI -92.2 to -1.6) NCT04594694 ↗
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 | — |