Last Updated | 31 March 2026

EFC16295

A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated paediatric Patients <12 Years of Age With Severe Hemophilia A
Site Status Queensland Children's Hospital
Queensland Children's Hospital (QLD)
John Hunter Children's Hospital (NSW)
Sydney Children's Hospital (NSW)
Monash Health Clayton (VIC)
Royal Children's Hospital (VIC)
Women's and Children's Hospital (SA)
Perth Children's Hospital (WA)
Royal Hobart Hospital (TAS)
Children's Hospital at Westmead (NSW)
Starship Children's Hospital (NZ)
Christchurch Hospital (NZ)
Preparing to Open
Open
Temporarily Closed
Closed
Complete
Adult Sites These sites are not monitored. Status may vary.
Diagnosis Stage Relapsed/Refractory
National Sponsor Bioverativ, a Sanofi company
Open Date 19/02/2021
Conditions Hemophilia A
Patient Range <11 years
Disease Type Leukaemia / Lymphoma / Blood Disorders
Study Type Interventional
International Sponsor N/A

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