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NCT02234323 · ClinicalTrials.gov registry record · Phase 3
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
A Phase 3 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
NCT02234323 is a Phase 3 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 108 participants.
The verdict
NCT02234323, a Phase 3 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.
Interventions
- BIOLOGICAL rFVIIIFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2015-01-12 |
| Est. Completion | 2019-09-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02234323
The ClinicalTrials.gov registry entry for NCT02234323 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ, a Sanofi company, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rFVIIIFc is the first listed.
NCT02234323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02234323 about?
NCT02234323 is a clinical study titled "An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A". The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVII...
What is the current status of trial NCT02234323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2015-01-12. Estimated completion is 2019-09-23.
What interventions are being tested in trial NCT02234323?
The interventions under investigation include: rFVIIIFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT02234323?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
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