An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN) (PEGIMPACT)
This study has been withdrawn prior to enrollment.
Merck Sharp & Dohme Corp.
First Posted: June 25, 2008
Last Update Posted: August 11, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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).
|Hepatitis C, Chronic Hepatitis C||Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)|
|Study Design:||Observational Model: Case-Only|
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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 Outcome Measures:
- Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters [ Time Frame: Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment ]
- Predictors of response at End-of-Treatment [ Time Frame: Assessed at the End-of-Treatment ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Biological: PegIntron (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)
Other Name: SCH 54031Drug: Rebetol (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)
Other Name: SCH 18908
Contacts and Locations
No Contacts or Locations Provided