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

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.

Timeline

Start

2016-01

Primary completion

2018-03

Completion

2018-09

Outcome

Missed primary endpoint

Stopped: “VTL-308 failed to meet its primary endpoint, all follow up studies were terminated”

registry analysis (superiority test); ELAD System vs Standard of Care (Control); p = 0.762; Hazard Ratio (HR) 0.913 (95% CI 0.509 to 1.640); Log Rank NCT02612428 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ELAD System	Cell therapy	—	—

Indications