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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Merck Sharp & Dohme LLC
- Primary Endpoint
- Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Arm 1
Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Arm 1
Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Intervention: Rebetol (ribavirin; SCH 18908) (Drug)
Outcomes
Primary Outcomes
Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications
Time Frame: 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
- 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)