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)
Public ClinicalTrials.gov record NCT03205163. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03205163
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Bioverativ, a Sanofi company
- Industry
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Interventions
- Advate (Low Dose) Biological
- Advate (High Dose) Biological
- BIVV001 (Low Dose) Biological
- BIVV001 (High Dose) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 27, 2017
- Primary completion
- Nov 11, 2018
- Completion
- Nov 11, 2018
- Last update posted
- Apr 18, 2022
2017 – 2018
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Los Angeles Medical Center | Los Angeles | California | 90007 | — |
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Michigan State University | East Lansing | Michigan | 48823 | — |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | — |
| Hemophilia Center of Western PA | Pittsburgh | Pennsylvania | 15213 | — |
| University of Washington | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03205163, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2022 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03205163 live on ClinicalTrials.gov.