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    Liver Transplant / Hepatology / Hepatitis / Liver Failure Clinical Trials

    Liver Disease Management & Transplant Program

    Adult Clinical Trials Main Page

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


     |  Primary Sclerosing Cholangitis  |  Hepatitis  |  Hepatitis B  |  Fatty Liver Disease (nonalcoholic steatohepatitis)  |  Liver Cancer - Hepatocellular Carcinoma (HCC)


    Active Trials


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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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    Hepatitis B

    Title: "BeNEG-DO": A Study of Clinical Outcomes, Immunologic Correlates and Genetic Predictors After Treatment Withdrawal in Early-Antigen Negative (HBeAg-) Chronic Hepatitis B Virus (HBV) Infection
    Description: The BeNEG-DO study will test the effects of stopping antiviral treatment in 80 people with E-antigen negative chronic hepatitis B who have been treated successfully for at least 3.7 years (192 weeks). For comparison, 30 people in a control group will continue therapy.
    Investigator: Stewart Cooper, MD
    Eligibility: HBeAg-CHB patients 18 years to 67 years with at least 192 weeks (3.7 years) of complete viral suppression (serum HBV DNA <50 IU/ml) on NA therapy
    Status: Active and open to enrollment
    Contact: Jae Shin, MPH, 415-600-3594 Email: Shinj3@sutterhealth.org about Study BeNEG-DO
    Contact: Jiajing Li, MPH, 415-600-3594 Email: Lij101@sutterhealth.org about Study BeNEG-DO


    Title: Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

    Description: This study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen
    Investigator: Stewart Cooper, MD
    Eligibility: Subjects 18 years and older with chronic hepatitis B infection
    Status: Active and open to enrollment
    Contact: Veronika Podolskaya, 415-600-1102, Email: PodolsV@cpmcri.org about Study Cohort

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    Fatty Liver Disease (nonalcoholic steatohepatitis)

    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: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
    Description: This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study)
    Investigator: Todd Frederick, MD
    Eligibility: Subjects 18 y/o and older, with cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.); compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event; severe portal hypertension defined as HVPG ≥12 mmHg
    Status: Open to enrollment
    Contact: Joshua Ross, 415-600-1369, Email: rossj1@sutterhealth.org.org about Study Conatus PHTN-6556-14

    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: Active and open to enrollment
    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 but not recruiting
    Contact: Anna von Bakonyi, 415-600-1107, Email: vonBaka@cpmcri.org about Study RESOLVE-IT


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    Liver Cancer - Hepatocellular Carcinoma (HCC)

    Please click here to see our Liver Cancer clinical trials.


    • updated 3/2018

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