NCT01471028

A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Alcohol-Induced Liver Decompensation (AILD)

Completed Phase 3 Results posted Last updated 22 January 2019

What this trial tests

Phase 3 trial testing ELAD treatment in Acute Alcoholic Hepatitis in 203 participants. Completed in 1 August 2015.

Timeline

1 February 2013

Primary endpoint
1 January 2015

1 August 2015

Quick facts

Lead sponsor	Vital Therapies, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	203
Start date	1 February 2013
Primary completion	1 January 2015
Estimated completion	1 August 2015
Sites	45 locations across United States, Australia, Spain, United Kingdom

Drugs / interventions tested

• ELAD treatment — full drug profile →
• Standard of care (Control) — full drug profile →

Conditions studied

• Acute Alcoholic Hepatitis — all drugs for Acute Alcoholic Hepatitis →

Sponsor

Vital Therapies, Inc. — full company profile →

Who can join

18 and older, any sex, with Acute Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Survival
  Time frame: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)
  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).

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial.
   Thompson J, Jones N, Al-Khafaji A, Malik S, et al · · 2018 · cited 92× · PMID 29171941 · DOI 10.1002/lt.24986
2. Acute-on-Chronic Liver Failure.
   Asrani SK, Simonetto DA, Kamath PS. · · 2015 · cited 36× · PMID 26188138 · DOI 10.1016/j.cgh.2015.07.008
3. New treatment options for alcoholic hepatitis.
   Shasthry SM, Sarin SK. · · 2016 · cited 15× · PMID 27099434 · DOI 10.3748/wjg.v22.i15.3892
4. Emerging Pharmacotherapies in Alcohol-Associated Hepatitis.
   Wakil A, Niazi M, Meybodi MA, Pyrsopoulos NT. · · 2023 · cited 10× · PMID 36647403 · DOI 10.1016/j.jceh.2022.06.012
5. Lipoprotein Z, a hepatotoxic lipoprotein, predicts outcome in alcohol-associated hepatitis.
   Hu K, Perez-Matos MC, Argemi J, Vilar-Gomez E, et al · · 2022 · cited 5× · PMID 34662439 · DOI 10.1002/hep.32203
6. End-stage liver failure: filling the treatment gap at the intensive care unit.
   Chamuleau RAFM, Hoekstra R. · · 2020 · cited 4× · PMID 31535298 · DOI 10.1007/s10047-019-01133-3
7. Emerging therapeutic regimens as alternatives to glucocorticoids for severe alcohol-associated hepatitis: a comprehensive review.
   Kumar R, Elangovan S, Asrani SK. · · 2026 · cited 1× · PMID 41715264 · DOI 10.3350/cmh.2025.1163