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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Acute On Chronic Hepatitis Biological: ELAD plus standard of care treatment Other: Standard of care Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Subjects With Acute On Chronic Hepatitis (AOCH)
Study Start Date : September 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


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)
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

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)
Other: Standard of care
Standard of care in the treatment of AOCH will be administered




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973817


Locations
Show Show 21 study locations
Sponsors and Collaborators
Vital Therapies, Inc.
Investigators
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Study Director: Robert Ashley, MS Vital Therapies, Inc.

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Responsible Party: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT00973817    
Other Study ID Numbers: VTI-206
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Vital Therapies, Inc.:
Hepatitis
AOCH
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections