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NCT01311648 · ClinicalTrials.gov registry record · Phase 3
BAY81-8973 Pediatric Safety and Efficacy Trial
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
NCT01311648 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 94 participants.
The verdict
NCT01311648, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A. The secondary objectives were * To assess the safety and efficacy of BAY81-8973 during surgeries. * To assess incremental recovery of BAY81-8973. * To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients \[PTPs\] and previously untreated patients \[PUPs\] / minimally treated patients \[MTPs\] - participation in PK sampling was voluntary and required consent).
Interventions
- BIOLOGICAL Recombinant Factor VIII (Kovaltry, BAY81-8973)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2011-06-09 |
| Est. Completion | 2020-10-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01311648
The ClinicalTrials.gov registry entry for NCT01311648 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 94 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 Recombinant Factor VIII (Kovaltry, BAY81-8973) is the first listed.
NCT01311648 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01311648 about?
NCT01311648 is a clinical study titled "BAY81-8973 Pediatric Safety and Efficacy Trial". The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A. The secondary objectives were * To assess the safety and efficacy of BAY81-8973 during surgeries. * To assess in...
What is the current status of trial NCT01311648?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2011-06-09. Estimated completion is 2020-10-27.
What interventions are being tested in trial NCT01311648?
The interventions under investigation include: Recombinant Factor VIII (Kovaltry, BAY81-8973) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01311648?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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