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PegIntron Injection Surveillance Plan (Study P04123)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00723931
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : December 13, 2010
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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)

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 1267 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: PegIntron Injection Surveillance Plan
Study Start Date : June 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated.
Criteria

Inclusion Criteria:

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

Signed written contract.

Exclusion Criteria:

  • None
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723931    
Other Study ID Numbers: P04123
First Posted: July 29, 2008    Key Record Dates
Results First Posted: December 13, 2010
Last Update Posted: November 4, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents