drugset / Trial / NCT04751188
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
RandomizedParallel-groupTriple-blindTreatment
Summary
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.
Timeline
- Start
- 2020-10-02
- Primary completion
- 2021-06
- Completion
- 2021-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bezafibrate | Small molecule | 200 mg | Oral |
| Background | Ursodeoxycholic Acid | Small molecule | — | — |