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NCT01829347 · ClinicalTrials.gov registry record · Phase 3
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
A Phase 3 study, sponsored by Vital Therapies.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT01829347: Clinical Trial Phase 3 study, sponsored by Vital Therapies.
NCT01829347 is a Phase 3 study that was terminated before completion, run by Vital Therapies. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01829347, a Phase 3 study, was terminated before completion, sponsored by Vital Therapies.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score \>0.45).
Primary Outcome
The primary endpoint of the study was a comparison of overall survival (OS) between ELAD-treated and Control groups, with protocol VTI-210E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (11 July 2016).
Interventions
- BIOLOGICAL ELAD
- OTHER Standard of Care treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-09 |
| Phase | Phase 3 |
Why NCT01829347 stopped before completion
NCT01829347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which ELAD is the first listed.
NCT01829347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01829347 about?
NCT01829347 is a clinical study titled "To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure". The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score \>0.45).
What is the current status of trial NCT01829347?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2014-04. Estimated completion is 2018-09.
What interventions are being tested in trial NCT01829347?
The interventions under investigation include: ELAD (BIOLOGICAL), Standard of Care treatment (OTHER).
Who is sponsoring clinical trial NCT01829347?
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 NCT01829347's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 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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