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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT00973817
First received: September 2, 2009
Last updated: April 1, 2013
Last verified: April 2013

September 2, 2009
April 1, 2013
September 2009
April 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
Time to progression at which a 5-point or greater MELD score is recorded relative to baseline [ Time Frame: At least 7 days and up to 28 days after baseline ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973817 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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).
Proportion of patients who have not progressed at 28 days (as defined in the primary endpoint) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute On Chronic Hepatitis
  • Biological: ELAD plus standard of care treatment
    Use of ELAD plus standard of care
    Other Name: Extra corporeal liver assist system
  • Other: Standard of care
    Standard of care in the treatment of AOCH will be administered
  • 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)
    Interventions:
    • Biological: ELAD plus standard of care treatment
    • Other: Standard of care
  • 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)
    Intervention: Other: Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
May 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 67 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00973817
VTI-206
Yes
Vital Therapies, Inc.
Vital Therapies, Inc.
Not Provided
Study Director: Robert Ashley, MS Vital Therapies, Inc.
Vital Therapies, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP