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Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis

Primary Biliary Cholangitis Clinical Trial

Official title:
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05450887
Study type Interventional
Source Nanjing Chia-tai Tianqing Pharmaceutical
Contact
Status Recruiting
Phase Phase 3
Start date September 23, 2021
Completion date June 2024
View Details
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