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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 is a Phase 3 study that has completed, run by Vital Therapies. The registered enrollment target is 203 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01471028
The ClinicalTrials.gov registry entry for NCT01471028 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 203 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 Standard of care (Control) is the first listed.
NCT01471028 reports 0 study locations.
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.
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