Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01458106 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A
A Phase 3 study, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
NCT01458106: Completed Phase 3 study, sponsored by Bioverativ Therapeutics.
NCT01458106 is a Phase 3 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458106, a Phase 3 study, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.
Primary Outcome
An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥50 EDs to rFVIIIFc. In addition, the incidence for all participants, regardless of their EDs to rFVIIIFc, was also summarized. An exact 95% CI for the proportion of participants with a
Interventions
- DRUG BIIB031 (rFVIIIFc)
- DRUG FVIII (PK subgroup only)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01458106 record still lists
NCT01458106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which BIIB031 (rFVIIIFc) is the first listed.
NCT01458106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458106 about?
NCT01458106 is a clinical study titled "Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A". The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIF...
What is the current status of trial NCT01458106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2012-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01458106?
The interventions under investigation include: BIIB031 (rFVIIIFc) (DRUG), FVIII (PK subgroup only) (DRUG).
Who is sponsoring clinical trial NCT01458106?
This trial is sponsored by Bioverativ Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01458106's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 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
- NCT05452889 · 71 participants · Early Phase 1
PET Image in PAH Patients
- NCT05766943 · 71 participants · NA
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
- NCT06229678 · 71 participants · Early Phase 1
Ketones, SGLT2, HFrEF
- NCT06377566 · 71 participants · Phase 2
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia