Efficacy and Safety of the Extracorporeal Liver Assist De... | NCT00973817

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ELAD	Experimental	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)	Biological: ELAD plus standard of care treatment Other: Standard of care
Standard of care	Other	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)	Other: Standard of care

Name	Type	Description	Arm Group Labels	Other Names
ELAD plus standard of care treatment	Biological	Use of ELAD plus standard of care	ELAD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression at which a 5-point or greater Model for End stage Liver Disease (MELD) score is recorded relative to baseline	This is based on death or the first observed increase of at least 5 points from Baseline MELD score (whichever occurs earlier) at least 24 hours after the ELAD® Treatment Period is ended and up to Study Day 91 (90 days following Baseline).	From Baseline up to Study Day 91

Secondary Outcomes

Measure	Description	Time Frame
Time to progression at which a 5-point or greater MELD score is recorded relative to baseline	A secondary Overall Survival analysis will use the same methodology as the primary time to progression efficacy analysis, except that an event will be defined as death. Secondary efficacy analyses will evaluate the proportion of progression free survivors (MELD score increased less than 5 points relative to the Baseline MELD score).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Previous liver transplant.
Previous participation in a clinical trial involving ELAD.

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical Center		Los Angeles	California	90048	United States
California Pacific Medical Center

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation