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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 is a Phase 3 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 71 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458106
The ClinicalTrials.gov registry entry for NCT01458106 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BIIB031 (rFVIIIFc) is the first listed.
NCT01458106 reports 0 study locations.
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.
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