Clinical trial NCT00704756: An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)
Official title: An Observational Multi-Center Study Exploring the Association of Safety, Patient Characteristics, Virological, and Histological Parameters With Patient Outcome (Relapse Rate, Achievement of Sustained Viral Response in Daily Clinical Practice in Belgium- PEGIMPACT
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.

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).


Eligibility criteria: 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications
timeFrame: 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 outcomes:
measure: Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters
timeFrame: Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment
measure: Predictors of response at End-of-Treatment
timeFrame: Assessed at the End-of-Treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Van Vlierberghe H, Adler M, Bastens B, Colle I, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Golstein P, Mulkay JP, Van Steenbergen W, Yap P, Nevens F, Denys AM, Brasseur JP. Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust study. Acta Gastroenterol Belg. 2010 Jan-Mar;73(1):5-11.