A Phase 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A
Phase of Trial: Phase I/II
Latest Information Update: 07 Feb 2018
At a glance
- Drugs BIVV 001 (Primary)
- Indications Haemophilia A
- Focus Adverse reactions
- Sponsors Bioverativ
- 29 Aug 2017 Status changed from planning to recruiting.
- 12 Jun 2017 According to a Bioverativ media release, U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application.
- 03 Feb 2017 New trial record