Study Evaluating rFIX; BeneFIX in Severe Hemophilia B - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00037557

Purpose

To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.

This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults. This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients. Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed, including inhibitor development, thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC agglutination. Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general.

Condition	Intervention	Phase
Hemophilia B	Drug: BeneFIX	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Children Less Than 6 Years of Age With Severe Hemophilia B

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia L1 syndrome

MedlinePlus related topics: Surgery

Drug Information available for: Factor IX

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.

Secondary Outcome Measures:

To measure the incremental recovery of rFIX in children following a 75-IU/kg bolus infusion.

Estimated Enrollment:	20
Study Start Date:	September 2002
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Severe hemophilia B
Less than 5 years of age
In the investigator's judgment, the patient and/or caregiver will be compliant to study procedures

Exclusion Criteria:

A currently detectable FIX inhibitor. A family history of inhibitors will not exclude the patient.
Impaired liver function
Impaired renal function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037557

Locations

United States, Colorado

Aurora, Colorado, United States, 80262
United States, Michigan

Detroit, Michigan, United States, 48201
United States, New Jersey

New Brunswick, New Jersey, United States, 08903
United States, North Carolina

Chapel Hill, North Carolina, United States, 27599-7220
United States, Ohio

Dayton, Ohio, United States, 45404
United States, Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3090A1-301
Study First Received:	May 17, 2002
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00037557 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Hemophilia B

Additional relevant MeSH terms:

Hemophilia B
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

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

ClinicalTrials.gov processed this record on November 27, 2009