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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 is a Phase 1 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 19 participants.
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.
Interventions
- BIOLOGICAL rFVIIIFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02083965
The ClinicalTrials.gov registry entry for NCT02083965 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 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.
NCT02083965 reports 0 study locations.
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.
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