A Study to Evaluate the Safety, and Tolerability, and Efficacy of Cilofexor in Patients With PSC
Cilofexor Clinical Trial
We have put together the following details about the Cilofexor trial to help you be as informed as possible when making your decision to take part.
Am I suitable to take part?
Not everyone is suitable, so we've provided some high-level information about who might be eligible. Your doctor will use additional criteria to assess your eligibility and will provide you with more detailed patient information about taking part if it looks like you are indeed suitable. You should read all of the patient information carefully before making your decision about taking part.
What if my hospital isn't running the trial but I want to take part?
If the clinical trial is not running in your hospital but you think you are eligible and are prepared to travel to one that is, please talk to your doctor or contact the research hospital in question. We will update this page as soon as Gilead publishes details of the hospitals that are ready to recruit patients.
|Trial Name||A Study to Evaluate the Safety, and Tolerability, and Efficacy of Cilofexor in Patients With PSC (PRIMIS)|
|Phase||Phase 3 trial|
|Intervention||Cilofexor/GS-9674 (or placebo) as a daily tablet|
|Recruiting now?||Some sites are recruiting.|
|Participating Centres and Contact||See PSC Support map current sites list on Clinicaltrials.gov for up to date status for each centre.|
|Liver disease diagnosis||You must have a diagnosis of PSC (not small duct PSC or other causes of liver disease)|
|Age||You must be an adult (18 to 70 years)|
|Is IBD allowed?||Yes - if it isn’t moderate to severely active.|
|Can I take part if I have a stent?||No|
|Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed?||No cholangitis attack within 30 days of screening|
|Can I take part if I have had a liver transplant?||No|
|Is cirrhosis allowed?||No|
|Previous studies and information||Gilead Announces Positive Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC) at The Liver Meeting® 2018
Trauner M, Gulamhusein A, Hameed B, Caldwell S, Shiffman ML, Landis C, Eksteen B, Agarwal K, Muir A, Rushbrook S, Lu X. The Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS‐9674) Improves Markers of Cholestasis and Liver Injury in Patients With Primary Sclerosing Cholangitis. Hepatology. 2019 Jan 19.
|Procedures and tests include:||Blood sample, Fibroscan, liver biopsy, MRCP, patient questionnaires.|
|Duration on study drug (or placebo)||96 weeks|
|Basic design of study||Randomised, Double Blind, Placebo Controlled Study|
|Link to Sponsor||Gilead Sciences, Inc.|