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Cilofexor

A Study to Evaluate the Safety, and Tolerability, and Efficacy of Cilofexor in Patients With PSC

Thinking of taking part?

  1. Check how suitable you are by looking at the information below.
  2. Check our map to see if you can get to a study site.
  3. 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.
  4. Got a question? Our Clinical Trials Guide has lots of information about how to join clinical trials, switching hospitals for trials and what's involved.
  5. Contact us if you need any help.

Key Information

Trial Name The PRIMIS trial
ClinicalTrials.gov Identifier NCT03890120
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.

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