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

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.

Official Title

Conditions

– Fulminant Hepatic Failure- Phase II

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further Details

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 Start

Eligibility & Criteria

Ages Eligible for Study: 18 Years – 50 Years, Genders Eligible for Study: Both Criteria Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy.Exclusion Criteria: No evidence of chronic liver disease.

Total Enrolment

18

Contact Details

[1] VitaGen