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

Clinical Trial Details

This clinical trial is to evaluate the experimental (investigational) study drug Elafibranor in men or women who have been diagnosed with Primary Biliary Cholangitis (PBC). Primary Biliary Cholangitis (PBC) is a chronic liver disease resulting from progressive destruction of the liver bile ducts. Elafibranor is considered to be experimental meaning it is not approved by the U.S. Food and Drug Administration (FDA).
   
This study is being conducted to learn more about the effects and safety of the study drug Elafibranor and compare the study drug with placebo (inactive ingredient). Eligible participants will be randomized (like a flip of a coin) to receive Elafibranor 80mg or placebo.
   
This study requires participants to arrive at the clinic over a period of approximately 6 years (72 months). Study participants will be compensated for their time.

Key Eligibility: 
  1. Men and women who are 18 to 75 years of age.
  2. Individuals diagnosed with Primary Biliary Cholangitis.

Detailed eligibility reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2011022955

ClinicalTrials.gov:

NCT04526665

Sponsor:

GFT505-319-1

Status

Open to Enrollment

Age Group

Adult

Sponsor