Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
Liver FibrosisHepatitis C2 moreThe primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin)...
Hepatitis CChronicThis randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic...
Chronic Hepatitis C InfectionThis study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).
Tenofovir in Asian Chronic Hepatitis B Patients
Chronic Hepatitis BTenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B virus (HBV) in various multiple-centre trials, with no cases of resistance encountered. However, its efficacy and resistance profile in the Asian population, which constitute the majority of chronic hepatitis B (CHB) patients, is unknown. Compared to other nucleoside analogues, TDF has been associated with relatively high rates of hepatitis B surface antigen (HBsAg) seroclearance. It would be interested to see if this could be reproduced. The investigators plan to report the serologic and virologic results of our 140 nucleoside analogue-experienced patients who were commenced on TDF.
Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus...
Hepatitis C VirusThe purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.
Study of a Novel Therapeutic Vaccine for Hepatitis C Virus
Hepatitis CHCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of chimpanzee and human origin respectively, bearing the same genetic information for HCV antigens (NS region). The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy volunteers with very good safety and immunogenicity results. HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination and Ad6NSmut as boosting vaccination. The trial includes: Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold standard therapy for hepatitis C); Arm B, in which vaccinated patients are not into therapy.
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis...
Hepatitis BChronicThis study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Autoimmune HepatitisUntreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Hepatitis C VirusTo identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis...
Chronic Hepatitis B VirusPediatricThe purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection