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NCT01580293 · ClinicalTrials.gov registry record · Phase 2
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
NCT01580293: Completed Phase 2 study, sponsored by Bayer.
NCT01580293 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 145 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01580293, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
Study Summary
Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability. The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A. 120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary. Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.
Primary Outcome
Annualized number of total bleeds was defined as the annualized sum of spontaneous bleeds and trauma bleeds. A participant who had the one-time increase in dose frequency was regarded as rescued. A rescue bleed was a bleed that occured after the dose frequency was increased. Rescue bleeds and periods were not considered for the annualized bleeding rate (ABR).
Interventions
- BIOLOGICAL BAY94-9027
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2012-04-23 |
| Est. Completion | 2019-11-21 |
| Phase | Phase 2 |
What the finished NCT01580293 record still lists
NCT01580293 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which BAY94-9027 is the first listed.
NCT01580293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01580293 about?
NCT01580293 is a clinical study titled "A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A". Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potent...
What is the current status of trial NCT01580293?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2012-04-23. Estimated completion is 2019-11-21.
What interventions are being tested in trial NCT01580293?
The interventions under investigation include: BAY94-9027 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01580293?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01580293's enrollment target sits among peer trials
145 498th of 2000 higher than 1,501 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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