Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)

NCT ID: NCT00725842

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-06-30

Brief Summary

The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be completed prior to the enrollment in the current study. The study will also aim to identify factors that are predictive of relapse. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.

Detailed Description

Non-probability sampling: The study population consists of adult patients over the age of 18 affected by CHC who were previously treated for the first time with Peg-IFN alfa-2b plus ribavirin and achieved end-of-treatment response. Five hundred ninety patients must be recruited in order to evaluate the objectives of the study. The patients must meet all inclusion criteria and not meet any of the exclusion criteria in order to be included in the study.

Conditions

Hepatitis C; Hepatitis C, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Peg-IFN alfa-2b + ribavirin

Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).

Peg-IFN alfa-2b

Intervention Type: BIOLOGICAL

Peg-IFN alfa-2b administered in accordance with approved labeling

Ribavirin

Intervention Type: DRUG

Ribavirin administered in accordance with approved labeling

Interventions

Peg-IFN alfa-2b

Peg-IFN alfa-2b administered in accordance with approved labeling

Intervention Type: BIOLOGICAL

Ribavirin

Ribavirin administered in accordance with approved labeling

Intervention Type: DRUG

Other Intervention Names

SCH 054031; SCH 018908

Eligibility Criteria

Inclusion Criteria

• The patient must demonstrate his/her continued willingness to participate in the study.
• The patient must be at least 18 years of age, of either gender.
• Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b + Ribavirin as first treatment for hepatitis C.
• Negative HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.

Exclusion Criteria

• Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4 weeks before study entry.
• Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
• Patients treated for a period shorter than the enrollment period.
• Patients co-infected with human immunodeficiency virus (HIV).
• Patients co-infected with hepatitis B virus (HBV).
• Patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05484

Identifier Type: -

Identifier Source: org_study_id