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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



    Cirrhosis / Portal Hypertension
     |  Hepatitis B  |  Fatty Liver Disease (nonalcoholic steatohepatitis)  |  Liver Cancer - Hepatocellular Carcinoma (HCC)


    Active Trials


    Cirrhosis / Portal Hypertension

    Ascites

    Title: A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites
    Description: The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12 months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
    Investigator: Todd Frederick, MD
    Eligibility: Subjects 21 years of age and older with a recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months, cirrhosis of any etiology and failure to respond to or intolerance to high dose diuretics.
    Status: Active and open to enrollment
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@cpmcri.org about Study MOSAIC

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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 and open to enrollment
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@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 and open to enrollment
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@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: Coming soon
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@cpmcri.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: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@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: Active and open to enrollment
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@cpmcri.org about Study RESOLVE-IT


    Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis

    Description: The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in adults with nonalcoholic steatohepatitis (NASH).
    Investigator: Edward W. Holt, MD
    Eligibility: Subjects 18-75 years of age with both clinical and MRI-based diagnosis of NAFLD and MR-elastography evidence of increased liver stiffness
    Status: Active and open to enrollment
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@cpmcri.org about Study GS-0976


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    Liver Cancer - Hepatocellular Carcinoma (HCC)

    Please click here to see our Liver Cancer clinical trials.


    • updated April 2017

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