A Phase 3 Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety Tolerability and Efficacy of GS-9674 in Non-Cirrhotic Subjects 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 - 70 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects willing and able to give informed consent prior to any study specific procedures being performed
    2. Subjects who are between the ages of 18 and 70 years old
    3. Subjects with diagnosis of large duct PSC based on cholangiogram (MRCP, ERCP, or PTC)
    4. Subjects who will have liver biopsy at Screening deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis
    5. Subjects who are on stable dose of UDCA for at least 6 months
    6. Subjects who are on stable doses of biologic treatments, immunosuppressants or systemic cortosteroids.
    7. Female subjects of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session
    8. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception as described in the protocol
    9. Subjects must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

You may not be eligible for this study if the following are true:

    1. Subjects who have history of cirrhosis, liver transportation or Cholangiocarcinomas or Ascending cholangitis
    2. Subjects with presence of a percutaneous drain or biliary stent
    3. Subjects who have other causes of liver disease including IgG4-related sclerosing cholangitis, autoimmune hepatitis/PSC overlap syndrome, secondary sclerosing cholangitis, small duct PSC
    4. Subjects who have current or prior history of malignancy, unstable cardiovascular disease, hypercoagulable condition, intestinal resection or malabsorptive condition.
    5. Subjects who are positive in HIV, HBV, HCV infectionc
    6. Subjects
    7. Subjects
    8. Subjects who is participating in another investigational study of a drug or device
    9. Subjects who have presence of any concomitant medical condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study
    10. Subjects with psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years
    11. Subjects with positive urine screen for amphetamines, cocaine or opiates
    12. Subjects with contraindications to magnetic resonance imaging



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