The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Primary Systemic (AL) Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT02312206
- Run by
- Prothena Biosciences Ltd.
- People needed
- 260
- Starts
- 2015-02-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2023-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- Stanford Cancer Institute (SCI) — Stanford, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Sylvester Cancer Center, University of Miami — Miami, Florida, United States
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
- Radiant Research Northwestern University — Chicago, Illinois, United States
- University of Chicago Medicine — Chicago, Illinois, United States
- Indiana University Cancer Center — Indianapolis, Indiana, United States
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States
- John Hopkins University School of Medicine — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Boston University School of Medicine — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University in Saint Louis — St Louis, Missouri, United States
- Newark Beth Israel Medical Center — Newark, New Jersey, United States
- Columbia University - College of Physicians & Surgeons — New York, New York, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- University of North Carolina Chapel Hill Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- The Cleveland Clinic - Main Campus — Cleveland, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Mayo Clinic Arizona — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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