Vital Therapies (NASDAQ:VTL) has enrolled the first subject in its Phase 3 trial designated, VTL-308, to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis. ELAD is an extracorporeal human allogeneic cellular liver therapy.
The trial is intended to enroll a minimum of 150 subjects, who will be randomized one-to-one to either ELAD therapy plus standard-of-care, or standard-of-care alone. The company expects to enroll subjects among roughly 40 sites in the U.S. and EU. There are now ten sites open for enrollment in VTL-308.
The primary endpoint is overall survival through at least 91 days assessed using the Kaplan Meier statistical method. Topline results from VTL-308 are anticipated in mid-2018.