PegIntron Injection Surveillance Plan (Study P04123) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723931

Purpose

Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where patients 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)

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	PegIntron Injection Surveillance Plan

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Postmarketing safety of PegIntron Injection; serious adverse events; adverse events; adverse events caused by misuse, abuse, and drug interactions; known adverse drug reactions, and adverse drug reactions not specified in the directions of use. [ Time Frame: Surveillance will be conducted after administration of PegIntron Injection and at 24 weeks after administration of PegIntron. ] [ Designated as safety issue: Yes ]
Postmarketing efficacy of PegIntron Injection. [ Time Frame: Surveillance will be conducted after administration of PegIntron Injection and at 24 weeks after administration of PegIntron. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with chronic hepatitis C Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where patients 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.

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 patients with chronic hepatitis C are generally treated.

Criteria

Inclusion Criteria:

Subjects 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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04123
Study First Received:	July 25, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00723931 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents

Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Peginterferon alfa-2b
Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Hepatitis C, Chronic
Interferon Alfa-2b

ClinicalTrials.gov processed this record on May 07, 2009