A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A
Active, no longer recruiting
Phase of Trial: Phase II/III
Latest Information Update: 14 Nov 2017
At a glance
- Drugs Damoctocog alfa pegol (Primary)
- Indications Haemophilia A
- Focus Pharmacokinetics; Therapeutic Use
- Acronyms PROTECT-VIII
- Sponsors Bayer; Bayer HealthCare
- 30 Oct 2017 According to a Bayer media release, the U.S. Food and Drug Administration (FDA) has accepted Bayer's Biologics License Application (BLA) filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant human Factor VIII compound, for the treatment of hemophilia A in adults and adolescents 12 years of age and over.
- 31 Aug 2017 According to a Bayer media release, the company has submitted a BLA to the US FDA for BAY94-9027 for the treatment of Hemophilia A. The regulatory submission is essentially based on the results from this trial.
- 11 Jun 2017 Planned End Date changed from 1 Feb 2017 to 15 Jan 2019.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History