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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 is a Phase 3 study that was terminated before completion, run by Vital Therapies. The registered enrollment target is 151 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02612428
The ClinicalTrials.gov registry entry for NCT02612428 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vital Therapies, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ELAD System is the first listed.
NCT02612428 reports 0 study locations.
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.
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