Last updated on February 2020

Safety Tolerability and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Primary Sclerosing Cholangitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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