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NCT04770935 · ClinicalTrials.gov registry record · Phase 1
To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
A Phase 1 study of Von Willebrand's Disease (VWD), sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 4
- Study locations
NCT04770935: Completed Phase 1 study of Von Willebrand's Disease (VWD), sponsored by Bioverativ, a Sanofi company.
NCT04770935 is a Phase 1 study of Von Willebrand's Disease (VWD) that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04770935, a Phase 1 study of Von Willebrand's Disease (VWD), has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 4
- Study locations
Study Summary
Primary Objective: -To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay Secondary Objective: -To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
Conditions Studied
Interventions
- DRUG efanesoctocog alfa (BIVV001)
Study Locations (4)
Other
- Investigational Site Number :2500001 - Lille
- Investigational Site Number :2500002 - Nantes
Iowa
- University of Iowa_Investigational Site Number :8400002 - Iowa City
Pennsylvania
- Hemophilia Center of Western Pennsylvania_Investigational Site Number :8400001 - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 1 |
What the finished NCT04770935 record still lists
NCT04770935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Von Willebrand's Disease (VWD) appearing as the primary indexed condition, and to 1 intervention - of which efanesoctocog alfa (BIVV001) is the first listed.
NCT04770935 reports a single indexed study location in Other, Iowa, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04770935 about?
NCT04770935 is a clinical study titled "To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)". Primary Objective: -To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coate...
What is the current status of trial NCT04770935?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-05-03. Estimated completion is 2022-12-20.
What conditions does trial NCT04770935 study?
This clinical trial studies the following conditions: Von Willebrand's Disease (VWD).
What interventions are being tested in trial NCT04770935?
The interventions under investigation include: efanesoctocog alfa (BIVV001) (DRUG).
Who is sponsoring clinical trial NCT04770935?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04770935 being conducted?
This trial has 4 study locations across Iowa, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04770935's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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