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NCT01178294 · ClinicalTrials.gov registry record · Phase 2
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT01178294: Completed Phase 2 study, sponsored by Baxalta now part of Shire.
NCT01178294 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178294, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
Primary Outcome
The initial serious ("qualifying") bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effe
Interventions
- BIOLOGICAL OBI-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-11-10 |
| Est. Completion | 2013-10-09 |
| Phase | Phase 2 |
What the finished NCT01178294 record still lists
NCT01178294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which OBI-1 is the first listed.
NCT01178294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01178294 about?
NCT01178294 is a clinical study titled "Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A". This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
What is the current status of trial NCT01178294?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2010-11-10. Estimated completion is 2013-10-09.
What interventions are being tested in trial NCT01178294?
The interventions under investigation include: OBI-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01178294?
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 NCT01178294's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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