Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Bayer.
NCT01311648 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Annualized number (mean +/- standard deviation) of total bleeds that occurred within 48 hours after all prophylaxis infusions (Part A: 6 months and at least 50 exposure days \[EDs\]; Part B: at least 50 EDs or until inhibitor development) was summarized and reported. Total bleeds: sum of spontaneous bleeds, trauma bleeds (only treated bleeds were classified as spontaneous or trauma), untreated bleeds and 'other' bleeds ('other' bleeds were infusions with reason given as 'other').
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 |
What the finished NCT01311648 record still lists
NCT01311648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Factor VIII (Kovaltry, BAY81-8973) is the first listed.
NCT01311648 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01311648's enrollment target sits among peer trials
94 1719th of 2000 higher than 279 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03747146 · 94 participants · NA
Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service
- NCT04061421 · 94 participants · Phase 1
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
- NCT04205968 · 94 participants · Phase 2
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
- NCT04464759 · 94 participants · Phase 1
A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI