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Hepatitis C, Chronic clinical trials

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NCT ID: NCT01221298 Completed - Hepatitis C Clinical Trials

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

NCT ID: NCT01220947 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

Start date: November 2010
Phase: Phase 2
Study type: Interventional

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

NCT ID: NCT01210404 Completed - Chronic Hepatitis C Clinical Trials

Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

Start date: February 2011
Phase: Phase 1
Study type: Interventional

Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.

NCT ID: NCT01206933 Completed - Clinical trials for Hepatitis C, Chronic

The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System

Start date: July 2010
Phase: N/A
Study type: Observational

Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.

NCT ID: NCT01200420 Completed - Hepatitis C Clinical Trials

Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.

NCT ID: NCT01200225 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study on The Impact of Insulin Resistance on Sustained Virological Response in Patients With Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Start date: February 2010
Phase: N/A
Study type: Observational

This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.

NCT ID: NCT01195181 Completed - Clinical trials for Chronic Liver Disease

Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.

Start date: September 2005
Phase: Phase 4
Study type: Interventional

Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the world, being the major cause of progressive liver disease, primary hepatic cancer and liver transplantation. Today, a "curative" therapy is available, that can eradicate the viral infection and determine the regression of liver fibrosis, also in cirrhotic subjects. The current standard-of-care for HCV chronic infection is combination therapy with peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but determines several side effects, that can reduce drug tolerance and hence, patient adherence to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®, F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b (PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only a single amino acid differentiates these types of IFN, administration strategies depend on their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also bioactivity. No comparative data are available on the benefits and costs of the licensed Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if, the benefit and favourable cost-efficacy of this antiviral therapy is well established and of large consensus. Recently, the first randomized controlled mega-trial to compare antiviral therapeutic efficacy in naïve patients with HCV-genotype 1 infection during different regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV, has been published, confirming a similar efficacy, of around 40%, obtained with the three schedules evaluated. In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the Regional Health Councillorship, has led to the development of a clinical and epidemiological observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common database that, since 2003, has prospectively collected data on a cohort of more than 3000 patients with chronic HCV infection and, among them, of 506 naïve subjects that consecutively underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV. The aim of this study was to rationalize and improve the social regional health program on antiviral treatment of chronic hepatitis C by assessing the different schedules utilization of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in the real clinical practice (Project A).

NCT ID: NCT01194037 Completed - Clinical trials for Chronic Hepatitis C Infection

A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.

NCT ID: NCT01185860 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.

NCT ID: NCT01183169 Completed - Hepatitis C Chronic Clinical Trials

Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The study is to investigate whether HCV GT1 patients with a history of non-response/relapse to PegIFN + RBV benefit from treatment with triple therapy of DEB025 plus Peg-IFN and ribavirin compared to triple treatment with placebo matching DEB025 plus Peg-IFN and ribavirin