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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 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. The trial reports 4 study locations across 3 states.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04770935
The ClinicalTrials.gov registry entry for NCT04770935 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ, a Sanofi company, which has 14 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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