Clinical trial NCT00725842: Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
Official title: Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatitis C previously treated with Peg-IFN alfa-2b + ribavirin in common clinical practice at approximately 60 centers in France.

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.

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).

Primary outcomes:
measure: Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
timeFrame: 24 weeks post end of treatment (EOT)
Secondary outcomes:
measure: Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment
timeFrame: 24 weeks post EOT
measure: Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response
timeFrame: Baseline and 24 weeks post EOT
measure: Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment
timeFrame: 72 weeks post EOT
Other outcomes:
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