PegIntron Injection Surveillance Plan (Study P04123)

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Signed written contract.

Exclusion criteria

None

Treatment and study plan

peginterferon alfa-2b (SCH 54031)

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.

Other names: PegIntron

Primary outcomes

Number of Participants That Reported a Serious Adverse Event

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

PegIntron Injection Surveillance Plan

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jul 29, 2008
Registry last updated: Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed