Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
Phase of Trial: Phase II
Latest Information Update: 11 Jun 2018
At a glance
- Drugs Birtamimab (Primary)
- Indications Amyloid light-chain amyloidosis
- Focus Adverse reactions
- Acronyms OLE
- Sponsors Prothena
- 23 Apr 2018 According to a Prothena media release, based on the results of PRONTO study, the independent data monitoring committee reviewed a futility analysis of the VITAL study and recommended a discontinuation of the VITAL study as well as the open label extension studies for futility.
- 23 Apr 2018 Status changed from active, no longer recruiting to discontinued, according to a Prothena media release.
- 23 Oct 2017 Planned End Date changed from 1 Dec 2017 to 1 Dec 2019.