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With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00704756

Acronym

PEGIMPACT

Enrollment

Registered

2008-06-25

Start date

2009-01-31

Completion date

2010-03-31

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Hepatitis C, Chronic

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).

Interventions

BIOLOGICALPegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron administered at 1.5 μg/kg body weight/week subcutaneously for up to 24 wks (Genotype \[G\] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)

DRUGRebetol (ribavirin; SCH 18908)

Rebetol administered based on body weight 800-1200 mg/day (\<65 kg : 800 mg, 65 - 85 kg : 1000 mg, \>85 kg : 1200 mg) orally for up to 24 wks (Genotype \[G\] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026