Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis

Completed · Phase 2/Phase 3

Conditions studied: Acute On Chronic Hepatitis

In brief

The purpose of this study is to investigate the safety and efficacy of the use of ELAD in patients with diagnosed Acute On Chronic Hepatitis, including Acute Alcoholic Hepatitis.

Key facts

Study ID

NCT00973817

Run by

Vital Therapies, Inc.

People needed

62

Starts

2009-09-01

Expected to finish

2011-05-01

Last updated by the study team

2013-04-08

Who can join

Age: 18 and older, up to 67. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 18</= 67 years; AND
• 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

You may not qualify if…

• Platelets <50,000mm at baseline; OR
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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