Trials / Completed
CompletedNCT03205163
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 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Bioverativ, a Sanofi company · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Advate (Low Dose) | Participants received a single IV low dose of Advate 25 IU/kg. |
| BIOLOGICAL | Advate (High Dose) | Participants received a single IV high dose of Advate 65 IU/kg. |
| BIOLOGICAL | BIVV001 (Low Dose) | Participants received single IV low dose of BIVV001 25 IU/kg. |
| BIOLOGICAL | BIVV001 (High Dose) | Participants received single IV high dose of BIVV001 65 IU/kg. |
Timeline
- Start date
- 2017-08-28
- Primary completion
- 2018-11-12
- Completion
- 2018-11-12
- First posted
- 2017-07-02
- Last updated
- 2022-04-19
- Results posted
- 2019-12-02
Locations
10 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03205163. Inclusion in this directory is not an endorsement.