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 August 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: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Severe Acute Alcoholic Hepatitis
Biological: ELAD
Other: Standard of Care treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vital Therapies, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • To evaluate the proportion of survivors at Study Days 28 and 91. [ Time Frame: Study Days 28 and 91. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Standard of Care (Control)
Standard of care is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD.EASL Guidelines.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829347

Contacts
Contact: Andrew Henry 858-673-6840 ext 1844 ahenry@vitaltherapies.copm
Contact: Michael Stephens 858-924-1991 mstephens@vitaltherapies.com

Locations
United States, Florida
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Eva Pavicic, BSN    305-243-2148      
Contact: Kalyan Bhamidimarri, MD    305-243-3333    kbhamidimari@med.miami.edu   
Principal Investigator: Kalyan Bhamidimarri, MD         
United States, Minnesota
University of Minnesota Medical Center - Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Melissa Cohen    612-624-6649    Cohen045@umn.edu   
Contact: Julie Thompson, MD    612-625-7498    Thom0235@umn.edu   
Principal Investigator: Julie Thompson, MD         
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Juan Caballeria, MD    +34 93 227 17 13    CABALLER@clinic.ub.es   
Principal Investigator: Juan Caballeria, MD         
Hospital Reina Sofia Recruiting
Cordoba, Spain, 14004
Contact: José Luís Montero, MD    +34 957 01 03 28    jlm14005623@gmail.com   
Principal Investigator: José Luís Montero, MD         
Hospital Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Rafael Bañares, MD    +34 91 586 86 99    rbanares@telefonica.net   
Principal Investigator: Rafael Bañares, MD         
United Kingdom
Royal Free Hospital Recruiting
Hampstead, London, United Kingdom, NW3 2QR
Contact: Melrose Browne-Morgan    +44 020 7794 0500 ext 22522    melrose.browne-morgan@nhs.net   
Contact: Nicola Childs, RN    +44 020 7794 0500 ext 22522    nicola.childs@nhs.net   
Principal Investigator: Rajiv Jalan, MD         
Sponsors and Collaborators
Vital Therapies, Inc.
Investigators
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
Principal Investigator: Kalyan R Bhamidimarri, MD University of Miami
Principal Investigator: Julie Thompson, MD University of Minnesota Medical Center - Fairview
  More Information

Additional Information:
No publications provided by Vital Therapies, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01829347     History of Changes
Other Study ID Numbers: VTI-210
Study First Received: April 8, 2013
Last Updated: August 18, 2014
Health Authority: United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

Keywords provided by Vital Therapies, Inc.:
Liver failure
acute alcoholic hepatitis
patients failing steroid therapy

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014