A Study to Evaluate the Safety, and Tolerability, and Efficacy of Cilofexor in Patients With PSC
Thinking of taking part?
- Check how suitable you are by looking at the information below.
- Check our map to see if you can get to a study site.
- Contact the research team for more details if you think you are suitable. Check back regularly as we are adding more contact info every day.
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|Trial Name||The PRIMIS trial|
|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 for locations and contacts. Site list also available on Clinicaltrials.gov.|
|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||Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC)
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.|