NCT02612428

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

Terminated Phase 3 Results posted Last updated 22 January 2019

What this trial tests

Phase 3 trial testing ELAD System in Acute Alcoholic Hepatitis in 151 participants. Terminated before completion.

Timeline

1 January 2016

Primary endpoint
1 March 2018

1 September 2018

Quick facts

Lead sponsor	Vital Therapies, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	1 January 2016
Primary completion	1 March 2018
Estimated completion	1 September 2018
Sites	44 locations across United States, Austria, Germany, Ireland, Spain, United Kingdom

Drugs / interventions tested

• ELAD System — 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

Adults 18 to 49, 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 VTL-308E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (28 August 2018).
  The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTL-308E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (28 Aug 2018).

Sponsor's own description

The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.

The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.

Publications & conference data

8 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. Alcoholic liver disease: A current molecular and clinical perspective.
   Ohashi K, Pimienta M, Seki E. · · 2018 · cited 86× · PMID 31214376 · DOI 10.1016/j.livres.2018.11.002
3. Emerging medical therapies for severe alcoholic hepatitis.
   Tornai D, Szabo G. · · 2020 · cited 19× · PMID 32981291 · DOI 10.3350/cmh.2020.0145
4. Approaches for patients with very high MELD scores.
   Artru F, Samuel D. · · 2019 · cited 19× · PMID 32039352 · DOI 10.1016/j.jhepr.2019.02.008
5. Extracorporeal liver support and liver transplantation for acute-on-chronic liver failure.
   Ballester MP, Elshabrawi A, Jalan R. · · 2025 · cited 9× · PMID 37312660 · DOI 10.1111/liv.15647
6. Bacterial Infections in Patients With Severe Alcohol-Associated Hepatitis: Drivers of Organ Failure and Mortality.
   Buttler L, Stange J, Pyrsopoulos N, Hassanein T, et al · · 2025 · cited 3× · PMID 40332100 · DOI 10.1111/liv.70111
7. Beyond corticosteroids: A systematic review of novel therapeutic strategies in severe alcoholic hepatitis and 90-day survival.
   Quiñones-Calvo M, Alvarado-Jara R, García-Renedo P, Stallings E, et al · · 2025 · cited 1× · PMID 41024761 · DOI 10.3748/wjg.v31.i35.109987
8. Steroid therapy is linked to lower incidence of acute kidney injury in patients with severe alcohol-associated hepatitis.
   Buttler L, Stange J, Pyrsopoulos N, Hassanein T, et al · · 2025 · PMID 41354748 · DOI 10.1038/s41598-025-29912-4