Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

Vital Therapies, Inc.19 enrolled

Overview

The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.

Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fulminant Hepatic Failure

Interventions

ELADBIOLOGICAL

Standard of care (Control)OTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion criteria: * Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy * Weight not less than 40 kilograms * Not listed for organ transplant, but no medical contraindications for transplant Exclusion Criteria: * Listed for organ transplant at stud entry * History of jaundice for greater than 28 days at screening * Liver dysfunction due to trauma * Concomitant serious disease

Locations (7)

UCSD

San Diego, California, United States

University of Miami

Miami, Florida, United States

Emory School of Medicine

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of subjects reaching 30-Day survival

30-day survival

Time frame: Study Day 30

Secondary Outcomes

30-day transplant-free survival

Time frame: Study Day 30

Data from ClinicalTrials.gov

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