UVA Tracking #
HSR200395
Principal Investigator
Stephen H Caldwell
Contact
Holly McComb
Contact Email
Contact Phone
434.924.2853
Official Trial 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
Study Description
The Department of Hepatology seeks adults ages 18-75 with primary biliary cholangitis (PBC) for a research study. The purpose of the study is to determine how safe and effective a new drug, elafibranor, is to treat PBC.
You may be eligible for this study if you have PBC and have failed other treatments such as ursodiolol.
Study involves a blinded period of up to 104 weeks, then a long term extension period where you are guaranteed to receive the study drug. You will have to have ECGs, ultrasounds, and bone density scans during the study as well as answer questionnaires daily.
Study-related exams, tests and experimental medication are all provided free of charge.
Compensation
$75/visit