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Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A — XTEND-Kids  

Hemophilia A Clinical Trial

Official 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

Clinical Trial Summary

Primary Objective: - To evaluate the safety of BIVV001 in previously treated pediatric participants with hemophilia A. Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. - To evaluate the efficacy of BIVV001 for perioperative management. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the pharmacokinetics (PK) of BIVV001.

Clinical Trial Description

Study duration per participants was approximately 60 weeks (maximum 8 weeks for screening and 52 weeks of treatment). All participants completing or remaining at the end of study were offered participation in the planned extension trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04759131
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date February 19, 2021
Completion date January 18, 2023
View Details
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