Liver Transplant / Hepatology / Hepatitis / Liver Failure Clinical Trials

California Pacific CURRENTS: The online journal of CPMC Research Institute

Below is a listing of Liver Transplant / Hepatology / Hepatitis / Liver Failure Clinical Trials approved by CPMC’s Institutional Review Board:

Fatty Liver Disease (nonalcoholic steatohepatitis)

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.

Investigators

  • Raphael Merriman, MD

Eligibility Requirements

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

Contacts

Douglas Troyer, RN, 415-600-1369

 

Hepatitis C

There are currently no open studies. Please check back for updates. 

 

HCV with Renal Insufficiency

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

Investigators

Eligibility Requirements

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

Contacts

Juliana Ma, 415-600-1368

 

Hepatitis B

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

Investigators

Eligibility Requirements

Subjects 18 years and older with chronic hepatitis B infection

Status

Active and open to enrollment

Contacts

Veronika Podolskaya, 415-600-1102

 

"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.

Investigators

Eligibility Requirements

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

Contacts

Jae Shin, MPH, 415-600-3594; Jiajing Li, MPH, 415-600-3594

 

Cirrhosis / Portal Hypertension

Hepatic Encephalopathy

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

Investigators

Eligibility Requirements

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

Contacts

Douglas Troyer, RN, 415-600-1369

 

Ascites

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.

Investigators

Eligibility Requirements

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

Contacts

Douglas Troyer, RN, 415-600-1369