A Post-Marketing Surveillance (PMS) Study of Safety and Effectiveness in Patients With BeneFIX Treatment - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00484185

Purpose

To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including:

Unknown adverse reactions, especially serious adverse reactions
Changes in the incidences of adverse reactions under the routine drug uses
Factors that may affect the safety of the drug
Factors that may affect the effectiveness of the drug

Condition	Intervention	Phase
Hemophilia B	Drug: BeneFIX (coagulation factor IX (recombinant))	Phase IV

Genetics Home Reference related topics: hemophilia L1 syndrome

Drug Information available for: Factor IX

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Post-Marketing Surveillance (PMS) Study of Safety and Effectiveness in Patients With BeneFIX Treatment

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Drug: BeneFIX (coagulation factor IX (recombinant)) BeneFIX will be administered according to "Dosage and Administration" of the approval labeling

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic, secondary and tertiary medical centers

Criteria

Inclusion Criteria:

Any new patient given at least one dose of BeneFIX as per registered indications as stated in the product label/insert.

Exclusion Criteria:

Patients to whom BeneFIX is contraindicated as per local labeling;
Patients with known hypersensitivity to BeneFIX or any component of the test article
Patients with a known history of hypersensitivity to hamster protein.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484185

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Korea, Republic of
	Recruiting
Multiple Cities, Korea, Republic of

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3090X1-4403
Study First Received:	June 7, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00484185
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 16, 2009