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Hepatitis C, Chronic clinical trials

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NCT ID: NCT01641094 Completed - Chronic Hepatitis C Clinical Trials

Effect of Teleprevir in Triple Therapy on Intrahepatic Immunological Mechanisms

ETIM
Start date: May 2012
Phase: N/A
Study type: Observational

Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million people. The previous standard of care therapy of chronic HCV patients consists of pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has previously proven to offer therapeutic options to previous non-responders to the standard of care. Although, not all chronic HCV patients benefit from telaprevir and it is still not known why certain patients are also non-responsive to this triple therapy. In this study we try to understand why certain patients are also non-responsive to telaprevir, how triple therapy modulates the responsiveness to IFN-α and what the immunological consequences are of treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of HCV-RNA levels.

NCT ID: NCT01636778 Completed - Clinical trials for Hepatitis C, Chronic

Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000 /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate to a higher rate of sustained viral response.

NCT ID: NCT01634919 Completed - Chronic Hepatitis C Clinical Trials

Histologic Changes and Noninvasive Assessment in Hepatitis C Patients Treated With Peginterferon Alpha-2a and Ribavirin

Start date: July 2012
Phase:
Study type: Observational

•The purpose of this study is to compare the performance between liver biopsy and non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus ribavirin in patients with hepatitis C pre- and post-treatment

NCT ID: NCT01628692 Completed - Hepatitis C Virus Clinical Trials

Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

NCT ID: NCT01628094 Completed - Clinical trials for Hepatitis C, Chronic

ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This 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.

NCT ID: NCT01625338 Completed - Chronic Hepatitis C Clinical Trials

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

NCT ID: NCT01609933 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study

Start date: December 18, 2012
Phase: Phase 2
Study type: Interventional

A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous AbbVie/Abbott combination study.

NCT ID: NCT01609049 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis

STANDART
Start date: December 7, 2011
Phase: N/A
Study type: Observational

This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.

NCT ID: NCT01604850 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

FUSION
Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

NCT ID: NCT01604291 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

Start date: May 28, 2012
Phase:
Study type: Observational

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.