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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 is a Phase 1 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03205163
The ClinicalTrials.gov registry entry for NCT03205163 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 0 conditions, and to 4 interventions - of which Advate (Low Dose) is the first listed.
NCT03205163 reports 0 study locations.
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.
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