Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)

NCT00832728 | Withdrawn Phase 2

• 1 other identifier: VTI-202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

Brief Summary

This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical therapy for FHF plus the ELAD® system, or standard medical therapy alone, with the latter defined as conventional therapy for FHF determined to be clinically appropriate by the treating physician.

Conditions

Fulminant Hepatic Failure

Outcome Measures

Primary Outcomes (2)

• The effect of ELAD® therapy: 1) as a bridge-to-transplant/recovery and 2) on 30-day transplant-free survival in subjects with FHF

  30 day

• To assess its safety when used for a minimum of 3 days or up to a maximum of 30 days of treatment

  30 day

Study Arms (2)

ELAD

ACTIVE COMPARATOR

ELAD Therapy + Standard of Care

Other: Standard of Care; Device: ELAD®

Standard of Care

OTHER

Hospital based standard of care for acute liver failure

Other: Standard of Care

Interventions

Standard of Care OTHER

Standard hospital protocol for the treatment of acute liver failure

ELAD; Standard of Care

ELAD® DEVICE

ELAD therapy

ELAD

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight ≥15 kilograms;
• Age ≥10 ≤65 years;
• Diagnosis of FHF;
• Patients must have been treated with a standard regimen of N-acetyl cysteine (NAC) involving a loading dose of 150mg/kg/hr over 1 hour followed by 12.5 mg/kg/hour x 4 hours then continuous infusion of 6.25 mg/kg for the remaining 67 hrs.
• Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements AND EITHER
• Known acetaminophen ingestion or diagnostic serum level, and at least one of the following:
• a. prothrombin time (PT) \>30 seconds (International Normalized Ratio (INR) \>6.5, OR; b. Encephalopathy Grade II, III or IV and at least one of the following: i. Arterial pH \<7.30 at ≥2 hours after initial diagnosis, OR; ii. renal failure documented by urine output less than 2 mL/kg/hr over 12 hours, OR; iii. creatinine \>2.5 mg/dL; OR
• Patients with Non-Acetaminophen-Induced FHF:
• a. Stage II, III or IV encephalopathy, and the presence of at least two of the following five criteria: i. Non-A/Non-B hepatitis or drug (non-acetaminophen) induced FHF; ii. Serum bilirubin \>17 mg/dL; iii. Patient ≥10 or \<40 years old; iv. Prothrombin time \>25 seconds (INR \> 3.5), AND/OR; v. Jaundice to encephalopathy time ≥7 days; OR

You may not qualify if:

• Patients \> 18 yrs of age with Cerebral Perfusion Pressures (CPP) ≤40 mm Hg for one hour or longer.
• Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
• Chronic liver disease;
• Concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, cancer, acute fatty-liver disease, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome;
• Portal hypertension (e.g., variceal bleed, caput Medusae, and clinically obvious ascites);
• Liver dysfunction due to trauma;
• Hemorrhage or irreversible brain death ( i.e. blood flow studies positive for herniation and/or pupillary reflex absent);
• Platelet count \<50,000/mm3 or reducing to \<80,000/mm3 over a 72 hr. period. (NOTE: Patient may be included at the physician's discretion if platelet count exceeds 50,000mm3 at time of initiation of therapy and can be managed through the administration of blood products);
• Mean Arterial Pressures (MAP) ≤50 mm Hg for one hour or longer as measured by an indwelling arterial line, OR; patients ≤18 years old and whose MAP is ≤40 mm Hg for one hour or longer;
• Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer;
• Clinical or radiographic evidence of stroke or intracerebral bleeding;
• Seizures uncontrolled by medication;
• Acute myocardial infarction based on clinical and/or electrocardiographic evidence;
• Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6, not corrected by medical management (including CVVH if indicated);
• Pregnancy as determined by βhCG results;

Sponsors & Collaborators

• Vital Therapies, Inc.: lead

Study Sites (12)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Loyola University Medical Center

Chicago, Illinois, 60153, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Louisiana State University Health Sciences Center-Shreveport

Shreveport, Louisiana, 71103, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

University of Rochester, Strong Memorial

Rochester, New York, 14642, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert A Ashley

  Vital Therapies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

US (12)