PegIntron Injection Surveillance Plan (Study P04123)
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|ClinicalTrials.gov Identifier: NCT00723931|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : December 13, 2010
Last Update Posted : November 4, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment|
|Hepatitis C, Chronic||Biological: Peginterferon alfa-2b (SCH 54031)|
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 Type :||Observational|
|Actual Enrollment :||1267 participants|
|Official Title:||PegIntron Injection Surveillance Plan|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
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.
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.
Other Name: PegIntron
Primary Outcome Measures :
- 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.
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