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PegIntron Injection Surveillance Plan (Study P04123)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00723931
First received: July 25, 2008
Last updated: March 11, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Hepatitis C, Chronic
 Biological: Peginterferon alfa-2b (SCH 54031)

Study Type: Observational
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 Schering-Plough:

Primary Outcome Measures:
  • Number of Participants That Reported a Serious Adverse Event [ Time Frame: 24 weeks after administration of PegIntron Injection ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1267
Study Start Date: June 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00723931     History of Changes
Other Study ID Numbers: P04123
Study First Received: July 25, 2008
Results First Received: November 9, 2010
Last Updated: March 11, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013