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

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ClinicalTrials.gov Identifier: NCT00973817
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE September 2, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date April 8, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2009)
Proportion of patients who have not progressed at 28 days (as defined in the primary endpoint) [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis
Official Title  ICMJE Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Subjects With Acute On Chronic Hepatitis (AOCH)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute On Chronic Hepatitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2012)
62
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2009)
80
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT00973817
Other Study ID Numbers  ICMJE VTI-206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vital Therapies, Inc.
Study Sponsor  ICMJE Vital Therapies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Ashley, MS Vital Therapies, Inc.
PRS Account Vital Therapies, Inc.
Verification Date April 2013

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