A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis — ELFIDENCE  

Primary Biliary Cholangitis (PBC) Clinical Trial

Official title: A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)

Status Recruiting

Clinical Trial Summary

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC).

Participants will also have inadequate response or intolerance to ursodeoxycholic acid (UDCA) a drug used to treat PBC.

PBC is a disease that progresses slowly. It causes damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.

The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many people with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.

This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). Each participant will be in the study up to about 7 years.

The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).

This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis (PBC)

• NCT number: NCT06016842
• Study type: Interventional
• Source: Ipsen
• Contact: Ipsen Clinical Study Enquiries
• Phone: See e mail
• Email: clinical.trials@ipsen.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 31, 2023
• Completion date: October 18, 2030