Early Prophylaxis Immunologic Challenge (EPIC) Study (EPIC)
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|ClinicalTrials.gov Identifier: NCT01376700|
Recruitment Status : Terminated (It became unlikely to achieve the study objective of 50% reduction over published inhibitor rates. The Data Monitoring Committee supported this decision.)
First Posted : June 20, 2011
Results First Posted : October 9, 2014
Last Update Posted : February 27, 2019
Baxalta now part of Shire
Baxter Innovations GmbH
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )
|Study Design||Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention|
Biological: Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)
|Recruitment Details||Enrollment was conducted in Europe and North America at 19 clinical sites.|
|Pre-assignment Details||22 participants were enrolled. One was a screen failure; one did not have screening laboratory assessments performed prior to study termination; and one met screening criteria, but was not exposed to investigational product prior to study termination. Therefore 19 participants were treated|
Early termination lead to:
- No statistical tests done on risk factors & inhibitor formation.
- FVIII consumption by participant not calculated due to large variation in # of EDs.
- FVIII-Specific Antibody Isotypes summary statistics not done.