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NCT01775618 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 73
- Enrollment target
NCT01775618 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 73 participants.
The verdict
NCT01775618, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 73 participants
- Enrollment target
Study Summary
Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. The current standard treatment for severe hemophilia A is infusion of FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. 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 being evaluated in 50 male subjects, \< 12 years of age, with severe Hemophilia A. These subjects will receive open label treatment with long-acting rFVIII for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and dose intervals may be adapted to the subject's clinical need. A second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. Patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary. Subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.
Interventions
- BIOLOGICAL BAY94-9027
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2013-05-29 |
| Est. Completion | 2020-02-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01775618
The ClinicalTrials.gov registry entry for NCT01775618 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 73 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.
NCT01775618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01775618 about?
NCT01775618 is a clinical study titled "Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A". Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. Th...
What is the current status of trial NCT01775618?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2013-05-29. Estimated completion is 2020-02-19.
What interventions are being tested in trial NCT01775618?
The interventions under investigation include: BAY94-9027 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01775618?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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