Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis
NCT ID: NCT00973817
Last Updated: 2013-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
62 participants
INTERVENTIONAL
2009-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ELAD
Use of ELAD for up to 6 days to stabilize liver function plus standard of care treatment plus standard of care treatment. Standard of care for acute on chronic hepatitis patients including medications and treatments typically given to patients admitted with acute hepatitis (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)
ELAD plus standard of care treatment
Use of ELAD plus standard of care
Standard of care
Standard of care in the treatment of AOCH will be administered
Standard of care
Standard of care for acute on chronic hepatitis patients including medications and treatments typically given to patients admitted with acute hepatitis (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)
Standard of care
Standard of care in the treatment of AOCH will be administered
Interventions
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ELAD plus standard of care treatment
Use of ELAD plus standard of care
Standard of care
Standard of care in the treatment of AOCH will be administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute decompensation of chronic liver disease over the preceding 30 days; AND
* MELD score between 18 and 35, inclusive; AND
* Subject or designated representative must provide Informed Consent
Exclusion Criteria
* Evidence of chronic renal failure as defined by a serum creatinine \>/= 2.5mg/dL as measured during the 1-6 month period prior to study entry. (Subject is not excluded with a creatinine \>2.5 mg/dL if deemed to be type-1 hepato-renal syndrome); OR
* Contraindication to renal replacement therapy (hemodialysis or hemofiltration); OR
* International Normalization Ratio (INR) \> 3.5; OR
* Septic shock as defined by a positive blood culture and two or more of the following:
* Systolic blood pressure \<90mmHg OR mean arterial pressure \<60mmHg;
* Tachypnea \> 20 breaths per minute OR a PaCO2\<32 mmHg;
* White blood cell count \< 4000 cell/mm3 OR \> 12000 cell/mm3 (\<4 x 10(9) or \>12 x 10(9) cells/L).
* Evidence of major hemorrhage as indicated by:
* requiring \>/= 4 units packed red blood cells within a 48 hour period prior to Screening, OR
* hemodynamic instability (sustained pulse \> 120 beats/min AND systolic blood pressure \< 100 mmHg over one hour)
Subjects with a recent history of gastrointestinal hemorrhage who have been successfully treated and remain hemodynamically stable for a period of 48 hours will then be eligible for the study if the investigator determines the subject to be at low risk for rebleeding; OR
* Evidence (by physical exam, history or lab evaluation) of significant concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome; OR
* Known history of hepatocellular carcinoma beyond the Milan criteria and/or portal vein thrombosis; OR
* Evidence of spontaneous bacterial peritonitis with uncontrolled infection; OR
* Evidence of brain death as determined by blood flow studies positive for herniation AND/OR absence of pupillary reflex; OR
* Systolic blood pressure \<85 mmHg OR MAP \<50mmHg at baseline; OR
* Requirement for escalating doses of vasopressor support OR of an alpha-adrenergic agent for one hour or longer AND evidence of hemodynamic instability; OR
* Subject at maximum vasopressor dose at Screen; OR
* Clinical or radiographic evidence of a new stroke or intracerebral bleeding; OR
* Seizures uncontrolled by medication; OR
* Acute myocardial infarction based on clinical and/or electrocardiographic evidence; OR
* Lung disease defined by a PaO2\<60mmHg on room air, acute respiratory distress syndrome, or a history of severe COPD or interstitial lung disease; OR
* Pregnancy as determined by beta-HCG results or lactation; OR
* Participation in another investigational drug, biologic, or device study within 1 month of enrollment. Subjects enrolled in an observational study will be eligible for this trial.
* Previous liver transplant.
* Previous participation in a clinical trial involving ELAD.
18 Years
67 Years
ALL
No
Sponsors
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Vital Therapies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Ashley, MS
Role: STUDY_DIRECTOR
Vital Therapies, Inc.
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
New York University Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Univ. of Rochester, Strong Memorial Hospital
Rochester, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University Hospitals Birmingham
Birmingham, England, United Kingdom
Kings College Hospital NHS Foundation Trust
London, England, United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Edinburgh Royal Infirmary
Edinburgh, , United Kingdom
St. James University Hospital
Leeds, , United Kingdom
Royal Free Hospital London
London, , United Kingdom
Countries
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Other Identifiers
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VTI-206
Identifier Type: -
Identifier Source: org_study_id
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