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    Liver Transplant / Hepatology / Hepatitis / Liver Failure Clinical Trials

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    Adult Clinical Trials Main Page

    Further protocol information can be found on the links below at ClinicalTrials.gov


     |  Primary Sclerosing Cholangitis  |  Hepatitis  |  Fatty Liver Disease (nonalcoholic steatohepatitis)


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    Primary Sclerosing Cholangitis

    Title: A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
    Description: This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).
    Investigator: Kidist Yimam, MD
    Eligibility: Subjects, 18 y/o and older, with a verified diagnosis of PSC for at least 12 months, with or without IBD.
    Status: Open to enrollment
    Contact: Anna von Bakonyi, 415-600-1107Email: vonBakA@cpmcri.org about the DUR-928 Study

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    Hepatitis

    Title: A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
    Description: This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
    Investigator: Kidist Yimam, MD
    Eligibility: Subjects, at least 18 years of age who have definite or probable AIH diagnosis and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies
    Status: Open to enrollment
    Contact: Anna von Bakonyi, 415-600-1107Email: vonBakA@cpmcri.org about the JKB-122 Study

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    Fatty Liver Disease (nonalcoholic steatohepatitis)

    Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)- ATLAS
    Description: The primary objective of this study is to test if the experimental drugs named Selonsertib (also known as "SEL"), GS-0976, GS-9674, and combinations of these drugs are safe, well-tolerated, and whether they can reduce fibrosis and the associated complications in subjects with fibrosis due to NASH.
    Investigator: Raphael Merriman, MD
    Eligibility: Subjects 18-80 years of age with bridging ( F3) fibrosis or compensated cirrhosis (F4) due to NASH with exclusion of other causes of liver disease based on medical history and/or centralized review of liver histology and prior history of decompensated liver disease including ascites, HE, or variceal bleeding.
    Status: Open to enrollment and recruiting patients
    Contact: Lin Ammar, 415-600-5708, Email: ammarl@sutterhealth.org about Study ATLAS

    Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
    Description: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis
    Investigator: Raphael Merriman, MD
    Eligibility: Subjects 18 to 70 y/o with a liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH CRN classification in the opinion of the central reader
    Status: Active but closed to enrollment
    Contact: Anna von Bakonyi, 415-600-1107, Email: vonBaka@cpmcri.org about Study GS-US-384-1943

    Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
    Description: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH
    Investigator: Raphael Merriman, MD
    Eligibility: Subjects 18 to 70 y/o with a liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH CRN classification in the opinion of the central reader
    Status: Active but closed to enrollment
    Contact: Anna von Bakonyi, 415-600-1107, Email: vonBaka@cpmcri.org about Study GS-US-384-1944

    Title: Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (Regenerate)
    Description: The primary objective of this study is to evaluate the effect of Obeticholic Acid treatment compared to placebo on liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
    Investigator: Raphael Merriman, MD
    Eligibility: Subjects 18 years of age and older with histologic evidence of NASH following a liver biopsy obtained no more than 6 months before Day 1 and histologic evidence of fibrosis stage 1, stage 2 or stage 3.
    Status: Open to enrollment and recruiting patients with stage 2 and stage 3 fibrosis
    Contact: Anna von Bakonyi, 415-600-1107, Email: vonBaka@cpmcri.org about Study Regenerate


    Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

    Description: The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis
    Investigator: Edward W. Holt, MD
    Eligibility: Subjects 18-75 years of age with histologic evidence of NASH and stage 1, 2 or 3 fibrosis on liver biopsy obtained no more than 6 months before study day 1
    Status: Open to enrollment and recruiting patients with stage 2 and stage 3 fibrosis
    Contact: Anna von Bakonyi, 415-600-1107, Email: vonBaka@cpmcri.org about Study RESOLVE-IT


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