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Hepatitis C, Chronic clinical trials

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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: NCT00724373 Completed - Clinical trials for Hepatitis C, Chronic

Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)

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

The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.

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: NCT00723931 Completed - Clinical trials for Hepatitis C, Chronic

PegIntron Injection Surveillance Plan (Study P04123)

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

Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.

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: 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.

NCT ID: NCT00722358 Completed - Chronic Hepatitis C Clinical Trials

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

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

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection