NCT03205163View on ClinicalTrials.gov

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)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 28, 2017

Primary Completion Date

November 12, 2018

Study Completion Date

November 12, 2018

Conditions
Hemophilia A
Interventions
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.

Trial Locations (10)

15213

Hemophilia Center of Western PA, Pittsburgh

39110

Mississippi Center for Advanced Medicine, Madison

46260

Indiana Hemophilia and Thrombosis Center, Indianapolis

48823

Michigan State University, East Lansing

52242

University of Iowa Hospitals & Clinics, Iowa City

90007

University of California Los Angeles Medical Center, Los Angeles

98104

University of Washington, Seattle

634-8521

Nara Medical University Hospital, Kashihara-shi

160-0023

Tokyo Medical University Hospital, Shinjuku-Ku

167-8515

Ogikubo Hospital, Tokyo

All Listed Sponsors
lead

Bioverativ, a Sanofi company

INDUSTRY

NCT03205163 - 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) | Biotech Hunter | Biotech Hunter