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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 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 145 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01580293
The ClinicalTrials.gov registry entry for NCT01580293 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BAY94-9027 is the first listed.
NCT01580293 reports 0 study locations.
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.
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