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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)  |  HCV with Renal Insufficiency  |  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

    Hepatic Encephalopathy

    Title: Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hyperammonemia and an Episode of Hepatic Encephalopathy STOP-HE Study
    Description: The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients
    Investigator: Todd Frederick, MD
    Eligibility: Subjects, 18 y/o and older, who are hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
    Status: Active and open to enrollment
    Contact: Douglas Troyer, RN, 415-600-1369, Email: TroyerD@cpmcri.org about Study Ocera STOP-HE

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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: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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    HCV with Renal Insufficiency

    Title: A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 HCV-Infected Subjects With Renal Insufficiency
    Description: This study will evaluate the safety, tolerability and antiviral efficacy of sofosbuvir with ribavirin (RBV) in participants with genotype 1 or 3 hepatitis C virus (HCV) infection who have chronic renal insufficiency
    Investigator: Maurizio Bonacini, MD
    Eligibility: Subjects 18 years and older with a chronic genotype 1 or 3 HCV infection and HCV RNA ≥ 10^4 IU/mL at screening
    Status: Active and open to enrollment
    Contact: Elaine Yan, 415-600-5743, Email: YanEY@cpmcri.org about Study GS-US-334-0154

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    Liver Cancer - Hepatocellular Carcinoma (HCC)

    Please click here to see our Liver Cancer clinical trials.


    • updated October 2016

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