MedTrace Logo

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With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)

NCT00704756 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2014-08-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31
Completion
2010-03-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704756 on ClinicalTrials.gov