NCT01376700

Early Prophylaxis Immunologic Challenge (EPIC) Study

A Phase 3b Clinical Study to Assess Whether Regular Administration of ADVATE in the Absence of Immunological Danger Signals Reduces the Incidence Rate of Inhibitors in Previously Untreated Patients With Hemophilia A

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: Male
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the minimization of immunological danger signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-08-26
• Primary completion: 2012-11-16
• Completion: 2012-11-16
• First posted: 2011-06-20
• Last updated: 2021-05-24
• Results posted: 2014-10-09

Locations

19 sites across 12 countries: United States, Austria, Bulgaria, Canada, Czechia, Germany, Lithuania, Netherlands, Poland, Russia, Serbia, Spain