PegIntron Injection Surveillance Plan (Study P04123)

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: Peginterferon alfa-2b (SCH 54031)

• Registration Number: NCT00723931
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Pegintron approval.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2010-11-09
• Results First Submitted QC: 2010-11-09
• Results First Posted: 2010-12-13
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1267

Inclusion Criteria

• Participants with chronic hepatitis C treated with peginterferon alfa-2b.

Signed written contract.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Chronic Hepatitis C	Peginterferon alfa-2b (SCH 54031)	Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with Chronic Hepatitis C are generally treated.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Reported a Serious Adverse Event	24 weeks after administration of PegIntron Injection	Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.
Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold	24 weeks after administration of PegIntron Injection.	Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.