Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
Public ClinicalTrials.gov record NCT01471028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Alcohol-Induced Liver Decompensation (AILD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01471028
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 203 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2013 (Type not available)
- Primary completion
- Jan 2015 (Actual)
- Completion
- Aug 2015 (Actual)
- Last update posted
- Feb 15, 2019
2013 – 2015
United States locations
- U.S. sites
- 35
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maricopa Integrated Health System (MIHS) | Phoenix | Arizona | 85008 | — |
| University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Sharp Coronado Hospital | Coronado | California | 92118 | — |
| Keck Hospital of University of Southern California | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Stanford School of Medicine/Stanford University Medical Center | Palo Alto | California | 94304 | — |
| University of California San Diego Medical Center - Hillcrest | San Diego | California | 92103 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Minnesota - Twin Cities Campus | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Rutgers University Hospital | New Brunswick | New Jersey | 08903 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15216 | — |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| The University of Texas Health Science Center - Texas Liver Institute | San Antonio | Texas | 78215 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84108 | — |
| Swedish Medical Center - Transplant Program | Seattle | Washington | 98104 | — |
| University of Washington - Harborview Medical Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01471028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 15, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01471028 live on ClinicalTrials.gov.