Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

August 24, 2004

Study Completion Date

August 24, 2004

Conditions
Hemophilia A
Interventions
DRUG

Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)

Trial Locations (5)

1135

National Medical Center, National Hemophilia Center, Budapest

1756

National Centre of Hematology and Transfusiology, Sofia

150 06

University Hospital Motol, Prague

00-5 76

Klinika Hemetologii I Onkologii Dzieciecej, Warsaw

50-345

Klinika Hematologii i Onkologii Dzieciecej, Wroclaw

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT00162019 - Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients | Biotech Hunter | Biotech Hunter