Status:
COMPLETED
Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency
Lead Sponsor:
Vital Therapies, Inc.
Conditions:
Acute Hepatitis
Chronic Hepatitis
Eligibility:
All Genders
19-69 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate on how well the ELAD system works in treating people with liver failure.
Detailed Description
This is a multicenter, open-label, randomized, concurrent control study of subjects with acute on chronic hepatitis. Subjects meeting the eligibility requirements of the study will be randomly assigne...
Eligibility Criteria
Inclusion
- Weight \>40 kilograms
- Age \>18 and \<70 years
- Acute decompensation of cirrhosis over the preceding 48-72 hour period
- Up to 4 weeks from symptom onset to presentation
- Presence of a precipitating event
- Either a MELD score of ≥32, or ≥24 with one or more of the following
- Severe encephalopathy of grade 3 or 4 on the Westhaven scale
- Renal dysfunction typical of type-1 hepato-renal syndrome, i.e. acute renal failure without evidence of elevated serum creatinine (\>2.5mg/dL) during the 1 to 6 months prior to study entry. Serum creatinine at study entry \>2.5mg/dL does not exclude the subject from enrolment
- SOFA score ≥9 at the initial Screening Visit
Exclusion
- Platelets \<50,000 or reducing to \<80,000 over a 72 hour period
- Renal failure: Serum creatinine ≥2.5 mg/dL as measured during the 1 - 6 month period prior to study entry. If a subject has a contraindication to renal replacement therapy (hemodialysis or hemofiltration), then the subject should be excluded from entry into the study
- Active sepsis. Sepsis will be defined as positive microbiological culture, ascitic white cell count \>450 cells/mm³ (or ascitic neutrophil count \>250 cells/mm³), or clinical signs and chest x-ray appearances for at least 48 hours without clinical improvement prior to randomization, or other evidence of infection not under control
- Evidence of major hemorrhage indicated by requiring ≥ 4 unit blood transfusion within a 24 hour period, 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
- Evidence (by physical exam, history, or laboratory evaluation) of significant concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, fatty-liver disease of non-alcoholic origin, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome;
- Known history of hepatocellular carcinoma beyond the Milan criteria and/or portal vein thrombosis
- Evidence of Small Bowel Perforation within 48 hours of treatment;
- Evidence of brain death as determined by blood flow studies positive for herniation and/or absence of pupillary reflex
- Mean Arterial Pressures (MAP) \< 50 mm Hg for one hour or longer;
- Requirement for escalating doses of vasopressor support of an alpha-adrenergic agent for one hour or longer and evidence of hemodynamic instability;
- Clinical or radiographic evidence of a new stroke or intracerebral bleeding
- Seizures uncontrolled by medication
- Acute myocardial infarction based on clinical and/or electrocardiographic evidence
- Lung disease defined by a PaO2 \<60 mm Hg or a history of severe COPD or interstitial lung disease
- Pregnancy as determined by βHCG results, or lactation
- Participation in another investigational drug, biologic, or device study within one month of enrollment
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00771446
Start Date
October 1 2008
End Date
April 1 2009
Last Update
April 12 2013
Active Locations (6)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
California Pacific Medical Center
San Francisco, California, United States, 94115
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114