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NCT02612428 · ClinicalTrials.gov registry record · Phase 3
Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD
A Phase 3 study, sponsored by Vital Therapies.
- Terminated
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT02612428: Clinical Trial Phase 3 study, sponsored by Vital Therapies.
NCT02612428 is a Phase 3 study that was terminated before completion, run by Vital Therapies. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02612428, a Phase 3 study, was terminated before completion, sponsored by Vital Therapies.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91. The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.
Primary Outcome
The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTL-308E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (28 Aug 2018).
Interventions
- BIOLOGICAL ELAD System
- OTHER Standard of Care (Control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-09 |
| Phase | Phase 3 |
Why NCT02612428 stopped before completion
NCT02612428 is an interventional study that assigns participants to a tested intervention. The registered 151 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which ELAD System is the first listed.
NCT02612428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02612428 about?
NCT02612428 is a clinical study titled "Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD". The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91. The secondary objective is to evaluate the proportion of survivors at St...
What is the current status of trial NCT02612428?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2016-01. Estimated completion is 2018-09.
What interventions are being tested in trial NCT02612428?
The interventions under investigation include: ELAD System (BIOLOGICAL), Standard of Care (Control) (OTHER).
Who is sponsoring clinical trial NCT02612428?
This trial is sponsored by Vital Therapies, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02612428's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 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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