Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

Completed · Phase 3

Conditions studied: Hemophilia B

In brief

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.

Key facts

Study ID

NCT00037557

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

20

Starts

2002-09-01

Expected to finish

2007-11-01

Last updated by the study team

2007-12-27

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Detroit, Michigan, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.