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NCT03205163 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)
A Phase 1 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03205163: Completed Phase 1 study, sponsored by Bioverativ, a Sanofi company.
NCT03205163 is a Phase 1 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03205163, a Phase 1 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.
Primary Outcome
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAE is defined as any AE that begins on or after the single dose of Advate but before the single dose of BIVV001. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anom
Interventions
- BIOLOGICAL Advate (Low Dose)
- BIOLOGICAL Advate (High Dose)
- BIOLOGICAL BIVV001 (Low Dose)
- BIOLOGICAL BIVV001 (High Dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2018-11-12 |
| Phase | Phase 1 |
What the finished NCT03205163 record still lists
NCT03205163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Advate (Low Dose) is the first listed.
NCT03205163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03205163 about?
NCT03205163 is a clinical study titled "A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)". The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.
What is the current status of trial NCT03205163?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-08-28. Estimated completion is 2018-11-12.
What interventions are being tested in trial NCT03205163?
The interventions under investigation include: Advate (Low Dose) (BIOLOGICAL), Advate (High Dose) (BIOLOGICAL), BIVV001 (Low Dose) (BIOLOGICAL), BIVV001 (High Dose) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03205163?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03205163's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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