NCT00704756

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With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)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• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis C, Chronic
• Hepatitis C

Interventions

Type	Name	Description
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)
DRUG	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)

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-06-25
• Last updated: 2014-08-11