Clinical trial NCT00973817: Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis
Official title: Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Subjects With Acute On Chronic Hepatitis (AOCH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute On Chronic Hepatitis
Keywords: Hepatitis
AOCH
Lead sponsor: Vital Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Time to progression at which a 5-point or greater Model for End stage Liver Disease (MELD) score is recorded relative to baseline
timeFrame: From Baseline up to Study Day 91
Secondary outcomes:
measure: Time to progression at which a 5-point or greater MELD score is recorded relative to baseline
timeFrame: From Baseline up to Study Day 91
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Univ. of Rochester, Strong Memorial Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
state: England
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
state: England
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital London
Study officials:
affiliation: Vital Therapies, Inc.
name: Robert Ashley, MS
role: STUDY_DIRECTOR
References: