Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery

PHASE3TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Factor X Deficiency
Interventions
BIOLOGICAL

FACTOR X

"Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."

Trial Locations (7)

28046

Unidad Coagulopatías, Congenitas, Edificio Dotacional, 1ra Planta Hospital Universito La Paz, Madrid

34098

Istanbul University Cerrahpasa Medicine Faculty Department of Pediatric Hematology, Istanbul

35100

Ege University School of Medicine, Departmant of Pediatric Hematology, Bornova

77030

University Of Texas Health Science Center, Gulf States Hemophilia and Thrombophilia Center 6655 Travis St, Houston

TR1 3LJ

Department of Hematology, Royal Cornwall Hospital,, Truro

NW3 2QG

The Katherine Dormandy Haemophilia Centre and Thrombosis Unit, The Royal Free Hospital,Pond Street, Hampstead

W12 0NN

Hammersmith Hospital, London

Sponsors
All Listed Sponsors
lead

Bio Products Laboratory

OTHER