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

Acute Alcoholic Hepatitis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Alcoholic Hepatitis
• Hepatitis, Alcoholic

• NCT number: NCT02612428
• Study type: Interventional
• Source: Vital Therapies, Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: January 2016
• Completion date: September 2018