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Phase III

Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis (PRIMIS)

  • Study HIC#:2000025197
  • Last Updated:07/15/2021

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

  • Age18 years - 75 years
  • GenderBoth
  • Start Date02/19/2020
  • End Date08/31/2023

Trial Purpose and Description

To evaluate whether GS-9674 reduces the risk of fibrosis progression among non-cirrhotic 

subjects with PSC

Eligibility Criteria

Key Inclusion Criteria:

  • Diagnosis of large duct PSC
  • Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
  • Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:
    • Platelet count ≥ 150,000/mm^3
    • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
    • ALT ≤ 8 x upper limit of the normal range (ULN)
    • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
    • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
    • Negative anti-mitochondrial antibody

Key Exclusion Criteria:

  • Current or prior history of any of the following:
    • Cirrhosis
    • Liver transplantation
    • Cholangiocarcinoma or hepatocellular carcinoma (HCC)
    • Ascending cholangitis within 30 days of screening
  • Presence of a percutaneous drain or biliary stent
  • Other causes of liver disease
  • Current or prior history of unstable cardiovascular disease
  • Current moderate to severely active inflammatory bowel disease (IBD)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Principal Investigator

Sub-Investigator

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