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NCT02083965 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
A Phase 1 study, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02083965: Completed Phase 1 study, sponsored by Bioverativ Therapeutics.
NCT02083965 is a Phase 1 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02083965, a Phase 1 study, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.
Primary Outcome
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Interventions
- BIOLOGICAL rFVIIIFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT02083965 record still lists
NCT02083965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which rFVIIIFc is the first listed.
NCT02083965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02083965 about?
NCT02083965 is a clinical study titled "Pharmacokinetics of rFVIIIFc at Two Vial Strengths". The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months ...
What is the current status of trial NCT02083965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2014-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02083965?
The interventions under investigation include: rFVIIIFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT02083965?
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 NCT02083965's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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