PegIntron Injection Surveillance Plan (Study P04123)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: July 29, 2008
Last Update Posted: November 4, 2015
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||PegIntron Injection Surveillance Plan|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
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.
|Study Start Date:||June 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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
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.
Contacts and Locations
No Contacts or Locations Provided