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Hepatitis C clinical trials

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NCT ID: NCT01016912 Completed - Clinical trials for Hepatitis C Infection

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

Start date: December 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

NCT ID: NCT01012895 Completed - Chronic Hepatitis C Clinical Trials

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Start date: December 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

NCT ID: NCT01011166 Completed - Clinical trials for Chronic Hepatitis C Infection

Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

Start date: November 2009
Phase: Phase 2
Study type: Interventional

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.

NCT ID: NCT01010906 Completed - Hepatitis C Clinical Trials

A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)

Start date: July 1, 2009
Phase: Phase 1
Study type: Interventional

This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.

NCT ID: NCT01010646 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Study Comparing the Tolerability and Viral Reduction of the Combination of IFN a-2b XL + Ribavirin Versus Peg IFN a-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4

COAT IFN
Start date: March 2010
Phase: Phase 2
Study type: Interventional

Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

NCT ID: NCT01008358 Completed - Clinical trials for Hepatocellular Carcinoma

Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

Start date: December 2008
Phase: Phase 2
Study type: Interventional

CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.

NCT ID: NCT01008280 Completed - Hepatitis C Clinical Trials

Baclofen to Reduce Alcohol Use in Veterans With HCV

BRAC
Start date: October 2010
Phase: Phase 4
Study type: Interventional

Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen is a novel treatment for alcohol use disorders that has minimal effect on the liver and may represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol use disorders.

NCT ID: NCT01006031 Completed - HIV Infection Clinical Trials

Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs. (*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after 12 weeks in treatment or breakthrough viremia while on treatment. Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a and ribavirin plasma concentrations on early viral response (EVR) and sustained viral response (SVR) in these patients. Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry.

NCT ID: NCT01001754 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection

EMERGE
Start date: May 2010
Phase: Phase 2
Study type: Interventional

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

NCT ID: NCT00998985 Completed - Hepatitis C Clinical Trials

A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)

Start date: February 23, 2010
Phase: Phase 1
Study type: Interventional

This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.