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NCT01181128 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
A Phase 3 study, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
NCT01181128 is a Phase 3 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 165 participants.
The verdict
NCT01181128, a Phase 3 study, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
Study Summary
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.
Interventions
- DRUG Factor VIII (rFVIIIFc)
- DRUG Advate®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01181128
The ClinicalTrials.gov registry entry for NCT01181128 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 165 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 Factor VIII (rFVIIIFc) is the first listed.
NCT01181128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01181128 about?
NCT01181128 is a clinical study titled "Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A". The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the effic...
What is the current status of trial NCT01181128?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2010-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01181128?
The interventions under investigation include: Factor VIII (rFVIIIFc) (DRUG), Advate® (DRUG).
Who is sponsoring clinical trial NCT01181128?
This trial is sponsored by Bioverativ Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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