Elafibranor in Primary Biliary Cholangitis

Summary

This study focuses on individuals who have been diagnosed with primary biliary cholangitis (PBC), a chronic liver disease resulting from progressive destruction of the liver bile ducts (intrahepatic bile ducts) and buildup of bile acids leading to inflammation and scarring of the liver (fibrosis). The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in patients with PBC who have inadequate response to or cannot tolerate standard therapy for PBC. Researchers will compare the effects of elafibranor against the effects of placebo (inactive substance). Participants will be randomly assigned to one of two treatment groups. One group will receive 80 mg of elafibranor, and the other will receive placebo.


Inclusion Criteria

  • Males or females age of 18 to 75 years (inclusive)
  • Definite or probable PBC diagnosis
  • ALP ≥ 1.67x upper limit of normal (ULN)
  • Total bilirubin (TB) ≤ 2x ULN
Show more

Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

Details
Disease Type/Condition

Biliary Disease

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

STUDY00000987

ClinicalTrials.gov ID

NCT04526665

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Biliary Disease

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

GFT505B-319-1

ClinicalTrials.gov ID

NCT04526665

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?