NCT00725842

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

Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Peg-IFN alfa-2b	Peg-IFN alfa-2b administered in accordance with approved labeling
DRUG	Ribavirin	Ribavirin administered in accordance with approved labeling

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-07-31
• Last updated: 2015-09-21
• Results posted: 2012-08-07