Fulminant Hepatic Failure
Conditions
Keywords
Fulminant Hepatic Failure
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALELAD
Sponsors
Vital Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects reaching 30-Day survival | Study Day 30 | 30-day survival |
Secondary
| Measure | Time frame |
|---|---|
| 30-day transplant-free survival | Study Day 30 |
Countries
United States
Outcome results
None listed