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

NCT00973817 | Completed Phase 2 DMC

• 1 other identifier: VTI-206
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 21

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.

Conditions

Acute On Chronic Hepatitis

Keywords

Hepatitis; AOCH

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Time to progression at which a 5-point or greater MELD score is recorded relative to baseline

  From Baseline up to Study Day 91

Study Arms (2)

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

Interventions

ELAD plus standard of care treatment BIOLOGICAL

Use of ELAD plus standard of care

Also known as: Extra corporeal liver assist system

ELAD

Standard of care OTHER

Standard of care in the treatment of AOCH will be administered

ELAD; Standard of care

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vital Therapies, Inc.: lead

Study Sites (21)

Cedars Sinai Medical Center

Los Angeles, California, 90048, 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

Indiana University

Indianapolis, Indiana, 46202, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Univ. of Rochester, Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University Hospitals Birmingham

Birmingham, England, B15 2PR, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, England, SE5 9RS, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

St. James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Royal Free Hospital London

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert Ashley, MS

  Vital Therapies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

US (15); GB (6)