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Hepatitis C clinical trials

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NCT ID: NCT00724620 Completed - Clinical trials for Hepatitis C, Chronic

PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1 (Study P04511)(COMPLETED)

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

This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1 patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks. At the end of this period, quantitative PCR will be used to determine the Early Viral Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

NCT ID: NCT00724464 Completed - Hepatitis C Clinical Trials

Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

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

The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.

NCT ID: NCT00724451 Completed - Hepatitis C Clinical Trials

Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)

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

The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.

NCT ID: NCT00724295 Completed - Hepatitis C Clinical Trials

Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)

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

This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

NCT ID: NCT00724230 Completed - Hepatitis C Clinical Trials

Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)

Start date: February 2006
Phase: N/A
Study type: Observational

The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

NCT ID: NCT00723892 Completed - Clinical trials for Hepatitis C, Chronic

Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

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

Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

NCT ID: NCT00723879 Terminated - Clinical trials for Hepatitis C, Chronic

Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

Start date: October 2004
Phase: N/A
Study type: Observational

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

NCT ID: NCT00723645 Completed - Clinical trials for Hepatitis C, Chronic

Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

FAST-4
Start date: April 2008
Phase: N/A
Study type: Observational

This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.

NCT ID: NCT00723632 Completed - Hepatitis C Clinical Trials

Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)

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

The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.

NCT ID: NCT00723242 Completed - Clinical trials for Chronic Hepatitis C Infection

The Role of Dendritic Cells in Hepatitis C Infection

Start date: April 2002
Phase: N/A
Study type: Interventional

The role of the dendritic cells, the most potent antigen presenting cells, in the establishment of chronic hepatitis C is not established. The study aims to define whether the dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the antiviral immune response they generate. The hypothesis is explored by investigating a group of patients prior to and after the initiation of standard treatment for hepatitis C with pegylated Interferon and Ribavirin.