drugset / Trial / NCT05450887
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with (primary biliary cholangitis)PBC. The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with PBC.
Timeline
- Start
- 2021-09-23
- Primary completion
- 2024-03-18
- Completion
- 2024-04-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obeticholic Acid | Small molecule | 10 mg | Oral |
| Background | Ursodeoxycholic Acid | Small molecule | 13 mg/kg | — |
| Background | Ursodeoxycholic Acid | Small molecule | 15 mg/kg | — |