An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)

Withdrawn

• Conditions: Hepatitis C; Hepatitis C, Chronic
• Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

• Registration Number: NCT00704756
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Study Start: 2009-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with PegIntron® and Rebetol® and reaching the End-of-Treatment time point.
• For the prospective component, evidence of treatment response at EOT after a complete course of therapy as per SmPC.
• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Subjects must be diagnosed with chronic hepatitis C (genotypes 1, 2, 3, 4, 5 or 6).
• Subjects must be free of any clinically significant disease that would interfere with study participation.

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Exclusion Criteria

• For prospective component of the study: patients not achieving End-of-Treatment response after a complete course of therapy as per SmPC.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Rebetol (ribavirin; SCH 18908)	Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Arm 1	PegIntron (peginterferon alfa-2b; SCH 54031)	Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.

Primary Outcome Measures

Name	Time	Method
Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications	Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment.

Secondary Outcome Measures

Name	Time	Method
Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters	Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment
Predictors of response at End-of-Treatment	Assessed at the End-of-Treatment