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Hepatitis C, Chronic clinical trials

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NCT ID: NCT00629967 Completed - Chronic Hepatitis C Clinical Trials

A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-1 Patients

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

The purposes of this study are: 1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve a sustained virological response (SVR) rate comparable to that observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype 1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV RNA at week 4) at 4 weeks. 2. To investigate the role of on-treatment virological responses among patients with 24 or 48 weeks treatment.

NCT ID: NCT00629824 Completed - Chronic Hepatitis C Clinical Trials

Pegylated Interferon Plus Ribavirin in Treating Older Patients With Chronic Hepatitis C

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

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated. The purposes of this study are: 1. To evaluate the efficacy of pegylated interferon-alpha 2a plus ribavirin combination therapy in older patients with chronic hepatitis C 2. To investigate the safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in older patients with chronic hepatitis C

NCT ID: NCT00624325 Completed - Chronic Hepatitis C Clinical Trials

Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders

SCIN-C
Start date: July 2007
Phase: Phase 2/Phase 3
Study type: Interventional

For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein.

NCT ID: NCT00623428 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

NCT ID: NCT00611819 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Two Different Treatments 24 vs 48 Weeks Chronic Hepatitis C Genotypes 2 and/or 3 in co-Infected HIV-HCV

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

The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment. Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment. In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%. In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks. In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.

NCT ID: NCT00610597 Completed - Clinical trials for Alcoholic Liver Disease

Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease

Start date: January 2005
Phase: N/A
Study type: Observational

Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.

NCT ID: NCT00606528 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy

Start date: February 2008
Phase: N/A
Study type: Observational

The main objective of this study is to assess whether a recently-developed bioassay for the protein FGL2 can be used to predict the progression and/or response to treatment of Hepatitis C Virus disease in patients with chronic HCV infection. The hypothesis is that increased levels of FGL2 and increased numbers of T regulatory cells are associated with a failure to respond to treatment.

NCT ID: NCT00606086 Completed - Clinical trials for Genotype 1 Chronic Hepatitis C

Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection

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

The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.

NCT ID: NCT00602784 Completed - Chronic Hepatitis C Clinical Trials

Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine

Start date: November 2002
Phase: Phase 2
Study type: Interventional

The objectives are 1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine. 2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine. 3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.

NCT ID: NCT00601770 Completed - Chronic Hepatitis C Clinical Trials

Virological Response Study of the HCV Vaccine IC41

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41. Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.