Study of Biostate® in Children With Hemophilia A

PHASE3CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Biostate

1 dose of 50 IU FVIII/kg body weight of Biostate administered intravenously on Day 1 in the PK component, followed by the Efficacy component for continuation of Biostate therapy, as required for a minimum of 50 exposure days.

Trial Locations (8)

64000

Study site, Monterrey

223040

Study site, Minsk

246040

Study site, Homyel

0179

Study Site, Tbilisi

01010

Study Site, Guatemala City

Unknown

Study Site, Beirut

Study Site, Dnipropetrovsk

Study Site, Lviv

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

CSL Behring

INDUSTRY