Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

December 17, 2004

Primary Completion Date

November 10, 2006

Study Completion Date

November 10, 2006

Conditions
Hemophilia A
Interventions
DRUG

Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)

"Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). Once the treatment regimen was established, the regimen was to be maintained for the duration of the study, unless clinical reasons necessitated a change.~The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care."

Trial Locations (1)

M5G 1X8

Hospital for Sick Children, Toronto

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT00189982 - Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101 | Biotech Hunter | Biotech Hunter