Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00037557
First received: May 17, 2002
Last updated: December 18, 2007
Last verified: December 2007

May 17, 2002
December 18, 2007
September 2002
Not Provided
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.
Not Provided
Complete list of historical versions of study NCT00037557 on ClinicalTrials.gov Archive Site
To measure the incremental recovery of rFIX in children following a 75-IU/kg bolus infusion.
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Study Evaluating rFIX; BeneFIX in Severe Hemophilia B
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemophilia B
Drug: BeneFIX
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2007
Not Provided

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
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00037557
3090A1-301
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP