Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency

NCT00771446 | Completed Phase 1 DMC

• 1 other identifier: VTI-201
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief Summary

Evaluate on how well the ELAD system works in treating people with liver failure.

Conditions

Acute Hepatitis; Chronic Hepatitis

Keywords

Hepatitis, acute; Acute Hepatitis OR Chronic Hepatitis

Outcome Measures

Primary Outcomes (1)

• To provide evidence that (1) subjects treated with ELAD have a higher 30-day transplant-free survival in subjects with AOCH than those not treated with ELAD, and (2) it is safe when used for 3 to 10 days of treatment.

  12 months

Study Arms (2)

ELAD (plus Standard of Care)

EXPERIMENTAL

Treatment with ELAD in addition to standard of care therapy Standard of care therapy defines uniform treatment for ascites, esophageal varices, dietary recommendations, etc.

Biological: ELAD plus standard of care treatment; Other: Standard of care treatment

Standard of Care (Control)

OTHER

Standard of care treatment Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

Other: Standard of care treatment

Interventions

ELAD plus standard of care treatment BIOLOGICAL

ELAD is a liver assist system - Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

ELAD (plus Standard of Care)

Standard of care treatment OTHER

Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

ELAD (plus Standard of Care); Standard of Care (Control)

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vital Therapies, Inc.: lead

Study Sites (6)

Scripps Clinic

La Jolla, California, 92037, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hepatitis, Chronic; Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd Frederick, MD

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

• Donald Hillebrand, MD

  Scripps Green Hospital

  PRINCIPAL INVESTIGATOR

• Helen Te, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Robert Brown, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Lena Napolitano, MD

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

• Winfred Williams, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 13, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

US (6)