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Hepatitis C clinical trials

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NCT ID: NCT00537407 Completed - Chronic Hepatitis C Clinical Trials

A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

Start date: September 2007
Phase: Phase 2
Study type: Interventional

Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and patients. The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only 40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.

NCT ID: NCT00535847 Completed - Hepatitis C Clinical Trials

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

Start date: October 2007
Phase: Phase 2
Study type: Interventional

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

NCT ID: NCT00532701 Completed - Chronic Hepatitis C Clinical Trials

Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR

Start date: November 2007
Phase: Phase 4
Study type: Interventional

Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

NCT ID: NCT00530972 Completed - HIV Infections Clinical Trials

Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies

PILOT-NR
Start date: March 2006
Phase: Phase 4
Study type: Interventional

To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.

NCT ID: NCT00529568 Completed - Clinical trials for Hepatitis C, Chronic

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

NCT ID: NCT00529321 Completed - Clinical trials for Hepatitis C, Chronic

Immunotherapy With TG4040 in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus

Start date: December 2006
Phase: Phase 1
Study type: Interventional

The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040 in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1). Patients will be sequentially treated at an escalting dose of TG4040. All patients will be followed up to at least 6 months after his/her first injection. In addition, all patients treated at the highest dose will receive a TG4040 boost injection 6 months after the first injection, and will be followed up during an additional 6-month period.

NCT ID: NCT00528528 Completed - Chronic Hepatitis C Clinical Trials

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

NCT ID: NCT00527774 Completed - Quality of Life Clinical Trials

Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients

Start date: September 2007
Phase: N/A
Study type: Observational

The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine characteristics that can be linked to poor clinical outcome and to examine the hypothesis that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization, cardiovascular and all-cause mortality.

NCT ID: NCT00527540 Completed - Hepatitis C Clinical Trials

Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Start date: February 2007
Phase: Phase 3
Study type: Interventional

Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

NCT ID: NCT00519792 Completed - Chronic Hepatitis C Clinical Trials

Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

Start date: August 2007
Phase: Phase 1
Study type: Interventional

Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days. This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.