Date: 2017-06-12
Type of
information: Clinical trial authorisation
phase: 1-2
Announcement: clinical trial authorization
Company: Bioverativ (USA - MA)
Product: BIVV001 (also known as rFVIIIFc-VWF-XTEN)
Action
mechanism:
- fusion protein. BIVV001 is an engineered factor VIII molecule with a region of Fc dimer, von Willebrand Factor, and XTEN, a half-life extension technology licensed from Amunix.
- BIVV001 has been designed to provide once-weekly or less frequent prophylactic dosing intervals for hemophilia A.
- BIVV001 is the only investigational factor VIII therapy in development that is designed to overcome the von Willebrand factor ceiling, which is believed to impose a half-life limitation on current factor VIII therapies.
Disease: hemophilia A
Therapeutic
area: Rare diseases - Genetic diseases - Hematological diseases
Country:
Trial
details:
- The primary purpose is to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.(NCT03205163)
Latest
news:
- • On June 12, 2017, Bioverativ announced that the FDA has accepted the company’s Investigational New Drug (IND) application for BIVV001 (also known as rFVIIIFc-VWF-XTEN), a novel, investigational factor VIII therapy designed to potentially extend protection from bleeds with prophylaxis dosing of once weekly or longer for people with hemophilia A.
Is
general: Yes
