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 Pediatric Patients

Australian & New Zealand Childrens Haematology/Oncology Group

ANZCHOG Children’s Cancer Clinical Trials Repository

Study Title

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 Pediatric Patients <12 Years of Age With Severe Hemophilia A

Protocol ID

EFC16295

Disease (Sub Disease)

Hemophilia A

Diagnosis Stage

Recurrent/ refractory

Location

QLD

Sponsor

Bioverativ, a Sanofi company

Links

External Registry ≫

Trial Status

Open

Sites

Queensland Children's Hospital

Study Type

Treatment

Phase

Phase 3

Age Eligibility

up to 12 years

International registry ID's

NCT04759131

Back to Registry

Study Title	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 Pediatric Patients <12 Years of Age With Severe Hemophilia A
Protocol ID	EFC16295
Disease (Sub Disease)	Hemophilia A
Diagnosis Stage	Recurrent/ refractory
Location	QLD
Sponsor	Bioverativ, a Sanofi company
Links	https://clinicaltrials.gov/ct2/show/NCT04759131
Trial Status	Open
Trial Open Date	19/02/2021
Sites	Queensland Children's Hospital
Study Type	Treatment
Phase	Phase 3
Age Eligibility	up to 12 years
International registry ID's	NCT04759131