- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00832273
Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
September 9, 2013 updated by: Vital Therapies, Inc.
Use of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Liver Failure: Uncontrolled Treatment Protocol to Provide Expanded Access With Cost Recovery
VTI had established other clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with acute on chronic (AOCH) (VTI-201, VTI-206) and fulminant hepatic failure (FHF) (VTI-202) and acute alcoholic hepatitis (AAH).
However, liver failure (LF) patients who do not qualify for other protocols may benefit from ELAD use.
In order to accommodate physician requests for the use of ELAD in LF patients who do not qualify for open Protocols, without the need to resort to individual Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery 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.
Study Overview
Detailed Description
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.
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 68 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Weight ≥15 kg;
- Age ≥10 and ≤70 years;
- MELD score of ≥24;
- Documented liver failure;
- Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements.
Exclusion Criteria:
Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.:
- Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures ≤40 mm Hg for one hour or longer.
- Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
- 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;
- Liver dysfunction due to trauma;
- Hemorrhage or irreversible brain death;
- Platelet count <50,000/mm3 or reducing to <80,000/mm3 over a 72 hour period;
- 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;
- Pregnancy as determined by βhCG results;
- ≤2 weeks postpartum;
- Eligible for an open ELAD clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (Estimate)
January 30, 2009
Study Record Updates
Last Update Posted (Estimate)
September 10, 2013
Last Update Submitted That Met QC Criteria
September 9, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTI-501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Failure
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Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Beijing Continent Pharmaceutical Co, Ltd.RecruitingAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
Tianjin Weikai Bioeng., Ltd.Tianjin Nankai HospitalUnknownLiver Failure, Acute on ChronicChina
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HLB Cell Co., Ltd.UnknownAcute-On-Chronic Liver Failure | Acute Liver FailureKorea, Republic of
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Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver Failure | Acute on Chronic Liver FailureIndia
-
Nanfang Hospital of Southern Medical UniversityCompletedLiver Injury | Liver Failure, Acute on Chronic
-
RenJi HospitalNot yet recruiting
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RenJi HospitalShanghai Institute of Biochemistry and Cell BiologyNot yet recruitingAcute-On-Chronic Liver Failure | Chronic Liver Failure
-
Institute of Liver and Biliary Sciences, IndiaRecruitingAcute on Chronic Liver FailureIndia
-
Cellaion SAActive, not recruitingAcute on Chronic Liver FailureBelgium, Spain, France, Austria, Denmark, Latvia, Germany, Bulgaria, Poland, Estonia, Italy, Lithuania, North Macedonia, Slovakia
Clinical Trials on ELAD®
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Vital Therapies, Inc.WithdrawnFulminant Hepatic FailureUnited States
-
Vital Therapies, Inc.TerminatedAcute Alcoholic HepatitisUnited States, Spain, United Kingdom, Germany, Austria, Ireland
-
Vital Therapies, Inc.WithdrawnAcute Liver Failure
-
Vital Therapies, Inc.CompletedAcute Alcoholic HepatitisUnited States, Spain, Australia, United Kingdom
-
Vital Therapies, Inc.TerminatedAcute Liver Failure | Fulminant Hepatic Failure | Primary Graft Non-Function | Surgically-Induced Liver FailureUnited States
-
Vital Therapies, Inc.CompletedFulminant Hepatic FailureUnited States
-
Vital Therapies, Inc.CompletedChronic Hepatitis | Acute HepatitisUnited States
-
Vital Therapies, Inc.CompletedAcute On Chronic HepatitisUnited States, United Kingdom
-
Vital Therapies, Inc.TerminatedSevere Acute Alcoholic HepatitisUnited States, Spain, United Kingdom, Germany
-
Dong-A ST Co., Ltd.CompletedFunctional DyspepsiaKorea, Republic of