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Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)

NCT00727311 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2302

Last updated 2015-10-09

Study results available
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Summary

The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C

Interventions

BIOLOGICAL

PegIntron (peginterferon alfa-2b; SCH 54031) injector

PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling

DRUG

Rebetol (ribavirin; SCH 18908)

Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-06-30
Completion
2009-06-30

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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 NCT00727311 on ClinicalTrials.gov