PegIntron Injection Surveillance Plan (Study P04123)

Hepatitis C, Chronic Clinical Trial

Official title:

PegIntron Injection Surveillance Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723931
• Other study ID #: P04123
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: November 2, 2015
• Start date: June 2006
• Est. completion date: November 2009

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1267
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Signed written contract.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis C, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Reported a Serious Adverse Event	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.	24 weeks after administration of PegIntron Injection	Yes
Primary	Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold	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.	24 weeks after administration of PegIntron Injection.	Yes