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

Vital Therapies

Status and phase: Completed; Phase 2

Conditions: Fulminant Hepatic Failure

Treatments: Other: Standard of care (Control); Biological: ELAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00030225

CR-202

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

ELAD

Experimental group

Description:

Treatment with ELAD, extracorporeal liver assist system and standard of care

Treatment:

Biological: ELAD

Standard of care (Control)

Other group

Description:

Standard of care for patients with fulminant hepatic (liver) failure

Treatment:

Other: Standard of care (Control)