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Terminated Phase 3 Interventional Results available

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis

ClinicalTrials.gov ID: NCT02312206

Public ClinicalTrials.gov record NCT02312206. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 12:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02312206
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Prothena Biosciences Ltd.
Industry
Enrollment
260 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2015 (Type not available)
Primary completion
May 2018 (Actual)
Completion
May 2018 (Actual)
Last update posted
Nov 14, 2023

2015 – 2018

United States locations

U.S. sites
32
U.S. states
24
U.S. cities
29
Facility City State ZIP Site status
Mayo Clinic Arizona Scottsdale Arizona 85259 —
City of Hope Duarte California 91010 —
Stanford Cancer Institute (SCI) Stanford California 94305 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
Mayo Clinic Jacksonville Florida 32224 —
Sylvester Cancer Center, University of Miami Miami Florida 33312 —
Winship Cancer Institute of Emory University Atlanta Georgia 30322 —
Radiant Research Northwestern University Chicago Illinois 60611 —
University of Chicago Medicine Chicago Illinois 60637 —
Indiana University Cancer Center Indianapolis Indiana 46202 —
Ochsner Clinic Foundation New Orleans Louisiana — —
John Hopkins University School of Medicine Baltimore Maryland 21205 —
Tufts Medical Center Boston Massachusetts 02111 —
Boston University School of Medicine Boston Massachusetts 02118 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Mayo Clinic Rochester Minnesota 55905 —
Washington University in Saint Louis St Louis Missouri 63110 —
Newark Beth Israel Medical Center Newark New Jersey 07112 —
Columbia University - College of Physicians & Surgeons New York New York 10032 —
Memorial Sloan-Kettering Cancer Center New York New York 10065 —
University of North Carolina Chapel Hill Comprehensive Cancer Center Chapel Hill North Carolina 27599-1651 —
Levine Cancer Institute Charlotte North Carolina 28211 —
Duke University Medical Center Durham North Carolina 27705 —
The Cleveland Clinic - Main Campus Cleveland Ohio 44195 —
Oregon Health & Science University Portland Oregon 97239 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
University of Pittsburg - Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Vanderbilt University Medical Center Nashville Tennessee 37232-5505 —
University of Texas; MD Anderson Cancer Center Houston Texas 77030 —
Huntsman Cancer Institute Salt Lake City Utah 84112 —
University of Washington Seattle Washington 98109 —
Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02312206, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 14, 2023 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02312206 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →