Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

PHASE4CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

January 4, 2006

Primary Completion Date

June 16, 2010

Study Completion Date

June 16, 2010

Conditions
Hemophilia A
Interventions
DRUG

Antihemophilic factor, recombinant, manufactured protein-free

Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator

DRUG

Antihemophilic factor, recombinant, manufactured protein-free

PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data

Trial Locations (29)

Unknown

Los Angeles

Chicago

Indianapolis

Minneapolis

New York

Oklahoma City

Portland

Hershey

Seattle

Vienna

Brno

Prague

Athens

Budapest

Debrecen

Pécs

Szeged

Szombathely

Florence

Milan

Gdansk

Krakow

Lublin

Warsaw

Wroclaw

Moscow

Ljubljana

Cardiff

Nottingham

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT00243386 - Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A | Biotech Hunter | Biotech Hunter