A Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Alcoholic Hepatitis Who Have Failed Steroid Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vital Therapies, Inc.
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01829347
First received: April 8, 2013
Last updated: May 23, 2014
Last verified: May 2014

April 8, 2013
May 23, 2014
April 2014
February 2015   (final data collection date for primary outcome measure)
Overall survival at Day 91 [ Time Frame: Study Day 1 through Study Day 91 ] [ Designated as safety issue: Yes ]
Overall survival of subjects will be assessed from study randomization (Day 1) through Study Day 91.
Same as current
Complete list of historical versions of study NCT01829347 on ClinicalTrials.gov Archive Site
To evaluate the proportion of survivors at Study Days 28 and 91. [ Time Frame: Study Days 28 and 91. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Alcoholic Hepatitis Who Have Failed Steroid Therapy
A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD® in Subjects With Acute Alcoholic Hepatitis (AAH) Who Have Failed Steroid Therapy

The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis who have failed steroid therapy.

Subjects with severe acute alcoholic hepatitis (sAAH) are often treated with steroids as soon as their diagnosis is confirmed. This study is to assess treatment with the ELAD System in subjects where the steroid treatment has failed. ELAD treatment is done continuously for up to 10 days in addition to standard of care treatment. The Control group (those chosen not to receive ELAD treatment) will also get standard of care treatment. Standard of care is defined as the usual care for diet, medications, treatment of complications that may arise, etc. for sAAH patients.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Acute Alcoholic Hepatitis
  • Biological: ELAD
    ELAD is an extracorporeal system that runs blood(plasma) through liver cells outside the body.
    Other Name: Liver assist system
  • Other: Standard of Care treatment
    Standard of care is predefined treatment for AAH complications (ascites, hepatic encephalopathy, varices, etc.)
    Other Name: Usual treatment for the disease
  • Experimental: ELAD (plus Standard of Care)
    ELAD is a cellular, extracorporeal, liver assist system. Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
    Interventions:
    • Biological: ELAD
    • Other: Standard of Care treatment
  • Standard of Care (Control)
    Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD.EASL Guidelines.
    Intervention: Other: Standard of Care treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
November 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 ;
  • Total bilirubin ≥ 8 mg/dL;
  • A clinical diagnosis of acute alcoholic hepatitis (AAH), confirmed by liver biopsy;
  • Subject must have failed steroid therapy according to Lille protocol (Lille score > 0.45) after at least 7 and not more than 9 days of steroid therapy.

Exclusion Criteria:

  • Platelet count < 50,000/mm3;
  • International Normalization Ratio (INR) > 3.0;
  • Evidence of infection unresponsive to antibiotics;
  • Evidence of more than one steroid regimen during this episode of liver failure;
  • Hospital admission for any episodes of liver decompensation within the past 2 months;
  • On mechanical ventilation;
  • Evidence of hemodynamic instability;
  • Evidence of active bleeding or of major hemorrhage;
  • Evidence of variceal bleeding within 7 days of Screening;
  • Evidence of occlusive portal vein thrombosis, or evidence of bile duct obstruction;
  • Evidence by physical exam, history, or laboratory evaluation of significant concomitant disease with expected life expectancy of less than 3 months;
  • Chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
  • Uncontrolled seizures;
  • Positive serologies for viral hepatitis B or C;
  • Pregnancy or lactation;
  • Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies;
  • Previous liver transplant;
  • Previous participation in a clinical trial involving ELAD;
  • Foreseeable eligibility for liver transplant during the 90-day study period;
  • Has a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or local equivalent) or any other Advanced Directive limiting Standard of Care in place;
  • Inability to provide an address for follow-up home health visits

And other inclusion/exclusion criteria

Both
18 Years and older
No
Contact: Andrew Henry 858-673-6840 ext 1844 ahenry@vitaltherapies.copm
Contact: Michael Stephens 858-924-1991 mstephens@vitaltherapies.com
Spain,   United Kingdom
 
NCT01829347
VTI-210
Yes
Vital Therapies, Inc.
Vital Therapies, Inc.
Not Provided
Study Director: Jan Stange, MD Vital Therapies, Inc.
Principal Investigator: Rajiv Jalan, MD Royal Free Hospital NHS Foundation Trust
Principal Investigator: Juan Caballeria, MD Hospital Clinic de Barcelona
Principal Investigator: José Luis Montero, MD Hospital Reina Sofia
Principal Investigator: Rafael Bañares, MD Hospital Gregorio Marañon
Vital Therapies, Inc.
May 2014

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