PegIntron Injection Surveillance Plan (Study P04123)

NCT ID: NCT00723931

Last Updated: 2015-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with Chronic Hepatitis C

Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with Chronic Hepatitis C are generally treated.

Peginterferon alfa-2b (SCH 54031)

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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PegIntron

Eligibility Criteria

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Inclusion Criteria

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

Signed written contract.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04123

Identifier Type: -

Identifier Source: org_study_id

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