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Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Vital Therapies, Inc..   Recruitment status was  Temporarily not available

First Received on January 29, 2009.   Last Updated on May 25, 2010   History of Changes
Sponsor: Vital Therapies, Inc.
Information provided by: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT00832273
  Purpose

VTI has established two clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with AOCH (VTI-201) and FHF (VTI-202). However LF patients who do not qualify for VTI-201 and VTI-202 may benefit from ELAD® use. In order to accommodate physician requests for the use of ELAD® in LF patients who do not qualify for Protocols VTI-201 and VTI-202 without the need to resort to individual Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery as described below, to provide for expanded access to ELAD® for those with LF. This uncontrolled Treatment Protocol has been designed to provide expanded access to ELAD® in subjects with LF while assuring that sufficient data are collected to adequately monitor ELAD® safety when used in this setting at multiple centers in the United States.


Condition Intervention
Liver Failure
Other: Standard of Care
Device: ELAD®

Study Type: Expanded Access     What is Expanded Access?
Official Title: Use of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Liver Failure: Uncontrolled Treatment Protocol to Provide Expanded Access With Cost Recovery

Further study details as provided by Vital Therapies, Inc.:

Intervention Details:
    Other: Standard of Care
    Hospital based protocol for standard of care for acute liver failure
    Device: ELAD®
Detailed Description:

Conventional therapies such as hemodialysis and hemoperfusion do not correct the metabolic abnormalities that are the hallmark of acute liver failure. Biologically active devices have heretofore been impractical because of limitations in the availability and viability of cultured liver cells of non-human origin. The yield of viable hepatocytes obtained for such purposes from large animals has been disappointing.

Vital Therapies Incorporated has developed an Extracorporeal Liver Assist Device (ELAD®) system that is comprised of a dialysis-type pump system and several "metabolically active" cartridges, each containing thousands of hollow fiber capillaries through which the subject's plasma "ultrafiltrate" fluid is circulated. Within each cartridge chamber, cloned immortalized human liver cells (C3A cells, U. S. patent #5,290,684) are grown in the extracapillary space (ECS) of the hollow fibers. These cells have been shown to exhibit certain characteristics of normal liver cells (e.g. albumin synthesis, conversion of ammonia to urea, synthesis of coagulation factors such as factor V etc.) and to be free of infectious or adventitious agents. During clinical therapy, the subject's ultrafiltrate (plasma-like) is pumped through the lumen (intracapillary space {ICS}) of the hollow fiber cartridge, and presumably, toxins found in the ultrafiltrate diffuse across the membrane where they can be metabolized by the C3A cells. These metabolites, along with albumin and other beneficial proteins produced by the cells, can then diffuse back across the membrane into the ICS and be returned to the subject. ELAD® therapy is designed to provide continuous liver support to a subject with compromised liver function, allowing time for the subject's native liver to regenerate to a healthy state, or to stabilize the subject until a suitable donor organ can be found for transplantation.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Weight ≥15 kg;
  2. Age ≥10 and ≤70 years;
  3. MELD score of ≥24;
  4. Subjects must be ineligible for Studies VTI-201 and VTI-202 (See Appendix D for eligibility requirements for Studies VTI-201 and VTI-202);
  5. Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements.

Exclusion Criteria:

  1. Cerebral Perfusion Pressure as measured by an intracranial pressure (ICP) monitor. (NOTE: In those cases where ICP monitor placement cannot be performed prior to study enrollment, this exclusion criterion will not apply):

    1. Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures (CPP) ≤40 mm Hg for one hour or longer.
    2. Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
  2. 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;
  3. Portal hypertension (e.g., variceal bleed, caput Medusae, and clinically obvious ascites);
  4. Liver dysfunction due to trauma;
  5. Hemorrhage or irreversible brain death ( i.e. blood flow studies positive for herniation and/or pupillary reflex absent);
  6. 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);
  7. 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;
  8. Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer;
  9. Clinical or radiographic evidence of stroke or intracerebral bleeding;
  10. Seizures uncontrolled by medication;
  11. Acute myocardial infarction based on clinical and/or electrocardiographic evidence;
  12. Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6, not corrected by medical management (including CVVH if indicated);
  13. Pregnancy as determined by βhCG results;
  14. ≤2 weeks postpartum;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832273

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Vital Therapies, Inc.
Investigators
Principal Investigator: Lena Napolitano, MD University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Robert Ashley, Chief Operating Officer, Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT00832273     History of Changes
Other Study ID Numbers: VTI-501
Study First Received: January 29, 2009
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Vital Therapies, Inc.:
Expanded access to ELAD® in patients with liver failure

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012