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PegIntron Injection Surveillance Plan (Study P04123)

NCT00723931 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1267

Last updated 2015-11-04

Study results available
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Summary

Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

Peginterferon alfa-2b (SCH 54031)

Surveillance will be conducted after administration of peginterferon alfa-2b (administered according to the directions on the products' labeling). PegIntron Injection for surveillance is a weight-based dosing product administered at a dose of 0.5/1.0 ug/kg or 1.5 ug/kg. Administration of treatment is not part of this study.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-11-30
Completion
2009-11-30

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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 NCT00723931 on ClinicalTrials.gov