Study Title
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 Pediatric Patients <12 Years of Age With Severe Hemophilia A
Protocol ID
EFC16295
Condition/s
Hemophilia A
Diagnosis Stage
Recurrent/ refractory
Location
QLD
Sponsor
Bioverativ, a Sanofi company
Links
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
| Study Title | 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 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 |