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NCT01376700 · ClinicalTrials.gov registry record · Phase 3
Early Prophylaxis Immunologic Challenge (EPIC) Study
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
NCT01376700: Clinical Trial Phase 3 study, sponsored by Baxalta now part of Shire.
NCT01376700 is a Phase 3 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 22 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01376700, a Phase 3 study, was terminated before completion, sponsored by Baxalta now part of Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing. Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protoc
Interventions
- BIOLOGICAL Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-08-26 |
| Est. Completion | 2012-11-16 |
| Phase | Phase 3 |
Why NCT01376700 stopped before completion
NCT01376700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM) is the first listed.
NCT01376700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01376700 about?
NCT01376700 is a clinical study titled "Early Prophylaxis Immunologic Challenge (EPIC) Study". 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 o...
What is the current status of trial NCT01376700?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2011-08-26. Estimated completion is 2012-11-16.
What interventions are being tested in trial NCT01376700?
The interventions under investigation include: Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01376700?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01376700's enrollment target sits among peer trials
22 1953rd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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