Early Prophylaxis Immunologic Challenge (EPIC) Study

PHASE3TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

August 26, 2011

Primary Completion Date

November 16, 2012

Study Completion Date

November 16, 2012

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)

Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.

Trial Locations (19)

Unknown

Indianapolis

New Brunswick

Vienna

Sofia

Kingston

Brno

Bonn

Bremen

Giessen

Munich

Vilnius

Nijmegen

Lublin

Olsztyn

Chelyabinsk

Krasnodar

Saint Petersburg

Belgrade

A Coruña

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Baxter Innovations GmbH

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY

NCT01376700 - Early Prophylaxis Immunologic Challenge (EPIC) Study | Biotech Hunter | Biotech Hunter