Primary Sclerosing Cholangitis Treatment Study

Clinical Trial Title

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of GS 9674 in non-cirrhotic subjects with primary sclerosing cholangitis.

Clinical Trial Protocol Description:

The purpose of this study is to see if an investigational drug, GS-9674, slows the scarring process in subjects with primary sclerosing cholangitis (PSC). Study participants will be randomly assigned to receive either study drug or placebo. Participants and the study staff will both be blinded to the assignment. Study participation will last approximately two years and will involve liver biopsies, radiology testing, and regular clinic visits.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are between 18 and 70 years of age.
  • Have a confirmed diagnosis of large duct PSC.
  • Avoid getting pregnant or getting someone pregnant for the duration of the study.
  • Are willing to undergo 2 liver biopsies.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Nikunj Shah, MD

Contact Information

Mary (Molly) Byrnes