Status:
TERMINATED
Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
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 Ribavi...
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 achi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00725842
Start Date
January 1 2009
End Date
June 1 2011
Last Update
September 21 2015
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