NCT02612428

Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Vital Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The ITT population includes all randomized subjects assigned to the group to which they were randomized, irrespective of actual treatment administered. Participant, Baseline Characteristics, and Outcome Measures used the ITT population. The safety population is defined as all subjects who are randomized based on actual treatment received. All serious adverse events and all non-serious adverse events analyses used the safety population.

Conditions

• Acute Alcoholic Hepatitis

Interventions

Type	Name	Description
BIOLOGICAL	ELAD System	An extracorporeal human hepatic cell-based liver treatment
OTHER	Standard of Care (Control)	Standard medical treatment as defined by the protocol

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-03-01
• Completion: 2018-09-01
• First posted: 2015-11-23
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

44 sites across 6 countries: United States, Austria, Germany, Ireland, Spain, United Kingdom