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NCT02502149 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
A Phase 3 study, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT02502149 is a Phase 3 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 24 participants.
The verdict
NCT02502149, a Phase 3 study, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously treated participants with severe hemophilia A. The secondary objectives are: to characterize the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial and 6000 IU/vial strengths; and to evaluate the safety of rFVIIIFc manufactured at the 15K scale.
Interventions
- BIOLOGICAL rFVIIIFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02502149
The ClinicalTrials.gov registry entry for NCT02502149 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 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 1 intervention - of which rFVIIIFc is the first listed.
NCT02502149 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02502149 about?
NCT02502149 is a clinical study titled "Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale". The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously treated participants with severe...
What is the current status of trial NCT02502149?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2015-08. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02502149?
The interventions under investigation include: rFVIIIFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT02502149?
This trial is sponsored by Bioverativ Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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