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NCT02312206 · ClinicalTrials.gov registry record · Phase 3
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
A Phase 3 study, sponsored by Prothena Biosciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
NCT02312206: Clinical Trial Phase 3 study, sponsored by Prothena Biosciences.
NCT02312206 is a Phase 3 study that was terminated before completion, run by Prothena Biosciences. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02312206, a Phase 3 study, was terminated before completion, sponsored by Prothena Biosciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
Study Summary
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 Outcome
Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first
Interventions
- OTHER Placebo
- DRUG NEOD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-05 |
| Phase | Phase 3 |
Why NCT02312206 stopped before completion
NCT02312206 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02312206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02312206 about?
NCT02312206 is a clinical study titled "The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis". 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 card...
What is the current status of trial NCT02312206?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2015-02. Estimated completion is 2018-05.
What interventions are being tested in trial NCT02312206?
The interventions under investigation include: Placebo (OTHER), NEOD001 (DRUG).
Who is sponsoring clinical trial NCT02312206?
This trial is sponsored by Prothena Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02312206's enrollment target sits among peer trials
260 1230th of 2000 higher than 767 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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