WHO ICTRP trial

Long-term safety and efficacy of BIVV001 in Previously Treated Patients with…

JPRN-jRCT2031210133 · Japan Primary Registries Network (JPRN) · Not Recruiting

Key facts

Trial ID JPRN-jRCT2031210133
Public title Long-term safety and efficacy of BIVV001 in Previously Treated Patients with hemophilia A
Scientific title A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation factor VIII Fc-von willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; BIVV001) in previously treated patients with severe hemophilia A
Primary sponsor Tanaka Tomoyuki
Registry Japan Primary Registries Network (JPRN)
Recruitment status Not Recruiting
Study type Interventional
Phase 3
Countries China;Japan;United States;Japan;Argentina;Japan;Australia;Japan;Belgium;Japan;Bulgaria;Japan;Canada;Japan;France;Japan;Germany;Japan;Greece;Japan;Hungary;Japan;Italy;Japan;Netherlands;Japan;Spain;Japa…
Conditions Hemophilia A
Interventions Drug: efanesoctocog alfa (BIVV001) Pharmaceutical form:Solution for Injection, Route of administration: Intravenous
Registration date Apr 6, 2021
Target size 262
Secondary IDs NCT04644575;2020-002215-22
Registry page jrct.niph.go.jp

At a glance

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