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NCT01471028 · ClinicalTrials.gov registry record · Phase 3
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
A Phase 3 study, sponsored by Vital Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
NCT01471028: Completed Phase 3 study, sponsored by Vital Therapies.
NCT01471028 is a Phase 3 study that has completed, run by Vital Therapies. The registered enrollment target is 203 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471028, a Phase 3 study, has completed, sponsored by Vital Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data up to a maximum of 5 years that will be included, as available, through VTI-208 study termination (after the last surviving enrolled subject completes Study Day 91). Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91. Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function, measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP) up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days 28 and 91. Progression is defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.
Primary Outcome
The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTI-208E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (31 July 2015).
Interventions
- OTHER Standard of care (Control)
- BIOLOGICAL ELAD treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01471028 record still lists
NCT01471028 is an interventional study that assigns participants to a tested intervention. The registered 203 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care (Control) is the first listed.
NCT01471028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01471028 about?
NCT01471028 is a clinical study titled "Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure". The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data u...
What is the current status of trial NCT01471028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2013-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01471028?
The interventions under investigation include: Standard of care (Control) (OTHER), ELAD treatment (BIOLOGICAL).
Who is sponsoring clinical trial NCT01471028?
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 NCT01471028's enrollment target sits among peer trials
203 1352nd of 2000 higher than 648 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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