Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Primary Biliary Cholangitis (PBC) Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid

Status Completed

Clinical Trial Summary

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cholangitis
Liver Cirrhosis, Biliary
Primary Biliary Cholangitis (PBC)

Clinical Trial Details

NCT number	NCT03124108
Study type	Interventional
Source	Genfit
Contact
Status	Completed
Phase	Phase 2
Start date	April 5, 2017
Completion date	October 31, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03188146` - Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
Not yet recruiting	`NCT03521297` - Probiotics in PBC Patients of Poor Response to UDCA	Phase 2
Recruiting	`NCT05896124` - CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)	Phase 2
Recruiting	`NCT06016842` - A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis	Phase 3
Completed	`NCT04047160` - Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)	Phase 1