Phase 3Terminated
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
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
- Sponsor
- Prothena Biosciences Ltd. (Industry)
- Enrolment
- 260 enrolled
- Conditions
- Primary Systemic (AL) Amyloidosis
- Interventions
- NEOD001; Placebo
- Ages
- adults, older adults
- Registry
- NCT02312206
Full record on ClinicalTrials.gov
From the registry
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
Primary outcomes
- Time to Composite of All-cause Mortality or Cardiac Hospitalization
History
Last registry update
Results first posted
Primary completion
Started
Registered