PegIntron Injection Surveillance Plan (Study P04123)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Biological: Peginterferon alfa-2b (SCH 54031)

Study type: Observational

Funder types: Industry

Identifiers

NCT00723931

P04123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,267 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Signed written contract.

Exclusion criteria

• None

Trial design

1,267 participants in 1 patient group

Participants with Chronic Hepatitis C

Description:

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

Treatment:

Biological: Peginterferon alfa-2b (SCH 54031)