A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 31 Mar 2018
At a glance
- Drugs Birtamimab (Primary)
- Indications Amyloidosis
- Focus Registrational; Therapeutic Use
- Acronyms VITAL
- Sponsors Onclave Therapeutics; Prothena
- 22 Dec 2017 Planned number of patients changed from 236 to 260.
- 22 Dec 2017 Planned End Date changed from 1 Feb 2019 to 1 Oct 2019.
- 22 Dec 2017 Planned primary completion date changed from 1 Jan 2018 to 1 Oct 2019.