Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis (SILVER)
April 1, 2013 updated by: Vital Therapies, Inc.
Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Subjects With Acute On Chronic Hepatitis (AOCH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Derby, United Kingdom, DE22 3NE
- Royal Derby Hospital
-
Edinburgh, United Kingdom, EH16 4SA
- Edinburgh Royal Infirmary
-
Leeds, United Kingdom, LS9 7TF
- St. James University Hospital
-
London, United Kingdom, NW3 2QG
- Royal Free Hospital London
-
-
England
-
Birmingham, England, United Kingdom, B15 2PR
- University Hospitals Birmingham
-
London, England, United Kingdom, SE5 9RS
- Kings College Hospital NHS Foundation Trust
-
-
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
San Francisco, California, United States, 94115
- California Pacific Medical Center
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
New York, New York, United States, 10016
- New York University Medical Center
-
Rochester, New York, United States, 14642
- Univ. of Rochester, Strong Memorial Hospital
-
Valhalla, New York, United States, 10595
- Westchester Medical Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Medical Center
-
Philadelphia, Pennsylvania, United States, 19102
- Drexel University College of Medicine
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University
-
-
Texas
-
Dallas, Texas, United States, 75246
- Baylor University Medical Center
-
Dallas, Texas, United States, 75203
- The Liver Institute at Methodist Dallas Medical Center
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ELAD
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)
|
Use of ELAD plus standard of care
Other Names:
Standard of care in the treatment of AOCH will be administered
|
|
Other: Standard of care
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)
|
Standard of care in the treatment of AOCH will be administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: From Baseline up to Study Day 91
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to progression at which a 5-point or greater MELD score is recorded relative to baseline
Time Frame: From Baseline up to Study Day 91
|
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).
|
From Baseline up to Study Day 91
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert Ashley, MS, Vital Therapies, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
September 2, 2009
First Submitted That Met QC Criteria
September 7, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
April 8, 2013
Last Update Submitted That Met QC Criteria
April 1, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTI-206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.