A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

Trial Website: https://clinicaltrials.gov/show/NCT01457768

A Randomized, DoubleBlind, Controlled Evaluation of Tenofovir DF versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B

This study is designed to evaluate the safety and antiviral activity of tenofovir disoproxil fumarate (TDF, tenofovir DF) compared to adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive either TDF or the approved hepatitis B therapy ADV. After 48 weeks all participants will be switched to open-label TDF.

Trial Website: https://clinicaltrials.gov/show/NCT00116805

Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety, and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy (STOP-HE)

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.

Trial Website: https://clinicaltrials.gov/show/NCT01966419

A randomized, double-blind, placebo-controlled, phase II study of sorafenib in subjects with hepatopulmonary syndrome

he main purpose of this clinical trial is to determine the safety and effects of the study drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood and the function of the lung vessels.

Trial Website: https://clinicaltrials.gov/show/NCT02021929

Simtuzumab (GS-6624) in the Treatment of Cirrhosis Due to NASH

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

Simtuzumab (GS-6624) in Treatment of Advanced Liver Fibrosis But Not Cirrhosis Secondary to NASH

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with non-alcoholic steatohepatitis (NASH).

It will consist of 2 phases:

A Phase 2 open-label study in patients with recurrent Genotype 1 hepAtitis C post orthotopic Liver transplAnt to eXplore the safety and efficacY of simeprevir and sofosbuvir with and without ribavirin

The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus (HCV) Genotype 1 infection.

Trial Website: https://clinicaltrials.gov/show/NCT02165189

A Study to Evaluate Chronic Hepatitis C Infection in Adult Liver Transplant Recipients

Clinical Study Protocol M12-999: Open-label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection

This is a study to evaluate chronic Hepatitis C Virus infection.

Trial Website: https://clinicaltrials.gov/show/NCT01782495