NCT01829347

A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD® in Subjects With Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

Terminated Phase 3 Results posted Last updated 12 February 2019

What this trial tests

Phase 3 trial testing ELAD in Severe Acute Alcoholic Hepatitis in 18 participants. Terminated before completion.

Timeline

1 April 2014

Primary endpoint
1 October 2015

1 September 2018

Quick facts

Lead sponsor	Vital Therapies, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 April 2014
Primary completion	1 October 2015
Estimated completion	1 September 2018
Sites	39 locations across United States, Germany, Spain, United Kingdom

Drugs / interventions tested

• ELAD — full drug profile →
• Standard of Care treatment — full drug profile →

Conditions studied

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

Sponsor

Vital Therapies, Inc. — full company profile →

Who can join

18 and older, any sex, with Severe 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 the time of database lock (11 July 2016), approximately 27 months
  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).

Sponsor's own description

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).

Publications & conference data

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

1. New treatment options for alcoholic hepatitis.
   Shasthry SM, Sarin SK. · · 2016 · cited 15× · PMID 27099434 · DOI 10.3748/wjg.v22.i15.3892
2. Extracorporeal liver support in severe alcoholic hepatitis.
   Parés A, Mas A. · · 2014 · cited 6× · PMID 25009371 · DOI 10.3748/wjg.v20.i25.8011