Liver Transplant/Hepatology/Hepatitis/Liver Failure
Liver Disease Management & Transplant Program Acute Liver Failure | Drug Induced Liver Injury | Hepatic Encephalopathy | Hepatitis C | ThrombocytopenicAcute Liver Failure
| Principal Investigator/Contact Information | Protocol Title | Patient Population | Recruitment Period |
| Principal Investigator: Timothy Davern, MD Contact: Katherine Fejardo 415-600-1518 | A Multi-Center Trial to Study Acute Liver Failure: Including Acte Liver Injury (ALI) | Subjects who have Acute Liver Failure, Acute Liver Injury. Subjects must be a hospitalized patient. | Open |
| Principal Investigator: Timothy Davern, MD Contact: Katherine Fejardo 415-600-1518 | A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study. | Subjects 18-70 years of age with Acute Liver Failure not thought due to Acetaminophen toxicity, mushroom poisoning, pregnancy-related liver failure, or malignancy. Subjects must be able to be evaluated and started on treatment within the first 24hrs of hospitalization or those who evolve to altered mentation if already in the hospital | Open |
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Drug Induced Liver Injury
| Principal Investigator/Contact Information | Protocol Title | Patient Population | Recruitment Period |
| Principal Investigator: Timothy Davern, MD Contact: Katherine Fejardo 415-600-1518 | Drug-Induced Liver Injury Network (DILIN) Protoco #2- A Multicenter, Longitudinal Study of Drug-and CAM-Induced Liver Injury. | Subjects 2 years or older who have taken a drug complementary alternative medicine product and developed a liver reaction within the past 6 months. Subjects must not have any other competing causes of liver injury, pre-existing autoimmune hepatitis or chronic biliary tract disease, acetaminophen hepatotoxicity, or liver transplantation prior to the development of drug- or CAM-induced liver injury. Subjects 2 years or older who have taken a drug or complementary alternative medicine product that has caused liver injury in others, but no reaction has occured in themselves. | Open |
| Principal Investigator: Timothy Davern, MD Contact: Katherine Fejardo 415-600-1518 | Drug-Induced Liver Injury Network (DILIN) Protocol #1- Idiosyncratic Liver Injury Associated with Drugs (ILIAD). | Subjects 2 years or older diagnosed with ILIAD due to medications are isoniazid, phenytoin, clavulanic acid/amoxicillin, valproic acid, trimethoprim-sulfamethoxazole, minocycline and quinolone antibiotics. Subjects 2 years or older who took the same medications but did not develop ILIAD. | Open |
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Hepatic Encephalopathy
| Principal Investigator/Contact Information | Protocol Title | Patient Population | Recruitment Period |
| Principal Investigator: Dr. Todd Frederick Contact: Nina Topic, RN 415-600-1721 | Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) in Patients with Hepatic Insufficiency | Subjects who are experiencing signs and symptoms of fulminant hepatic failure (FHF). | Open |
| Principal Investigator: Dr. Todd Frederick Contact: Nina Topic, RN 415-600-1721 | Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) in Patients with Hepatic Insufficiency | Subjects with acute decompensation of chronic liver disease (cirrhosis) | Coming Soon |
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Hepatitis C
| Principal Investigator/Contact Information | Protocol Title | Patient Population | Recruitment Period |
| Principal Investigator: Maurizio Bonacini, MD Contact: Catherine Carr 415-6001369 | A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics of Once-Daily Oral E5501 Tablets Used Up to 7 Days in Subjects with Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures | Subjects who have thrombocytopenia related to chronic liver disease and are scheduled to undergo an elective surgical or diagnostic procedure. | |
| Principal Investigator: Natalie Bzowej, MD Contact: Brian Macapinlac 415-600-1627 | A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients | Subjects chronic hepatitis C virus infection and have relapsed after interferon/ribavirin treatment. | Open |
| Principal Investigator: Natalie Bzowej, MD Contact: Anna Von Bakonyi, LVN 415-600-1107 | A Phase 2, Randomized, Double-Blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination with Pegasys® and Copegus® versus the Currently Approved Combination of Pegasys® and Copegus® in Treatment Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection | Genotype 1 or 4 subjects who have never been treated for Hepatitis C before (treatment naive) | Closed to enrollment |
| Principal Investigator: Natalie Bzowej, MD Contact: Rich Sommers 415-600-1578 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered with Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients with Chronic Hepatitis C Infection Visit this study on ClinicalTrials.gov. | Subjects who have genotype 1, chronic hepatitis C infection and have not previously received treatment. | Coming Soon |
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Thrombocytopenic
| Principal Investigator/Contact Information | Protocol Title | Patient Population | Recruitment Period |
| Principal Investigator: Natalie Bzowej, MD Contact: Allison Gilchrist, RN 415-600-1768 | Phase 3, double-blind, placebo controlled, multi-center trial to evaluate safety and efficacy of study drug (thrombopoietin-receptor agonist) to reduce the need for platelet transfusion in thrombocytopenic subjects w/chronic liver disease undergoing elective invasive procedures. | Male and female subjects who are 18 years or older, with chronic liver disease and thrombocytopenia with a platelet count of less than 50,000/μL. | Open |
| Principal Investigator: Natalie Bzowej, MD Contact: Allison Gilchrist, RN 415-600-1768 | Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin) | Male and female subjects who are 18 years or older, with chronic Hepatitis C and thrombocytopenia with a platelet count of less than 75,000/μL, who are eligible for peginterferon alfa-2a plus ribavirin therapy. | Open |
updated: 11/11/09
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