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

This study is not yet open for participant recruitment.
Verified October 2013 by Vital Therapies, Inc.
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01829347
First received: April 8, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine if treatment with the ELAD system is safe and effective in patients with acute alcoholic hepatitis.


Condition Intervention Phase
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.


Estimated Enrollment: 120
Study Start Date: December 2013
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 AAH complications (ascites, hepatic encephalopathy, varices, etc.)
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 AAH complications (ascites, hepatic encephalopathy, varices, etc.)
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:

Patients with acute alcoholic hepatitis (AAH) are often treated with steroids as soon as their diagnosis is confirmed. This study is to assess therapy with the ELAD system in patients where the steroid treatment is not working. 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 AAH 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829347

Contacts
Contact: Robert Ashley 520-289-3236 rashley@vitaltherapies.copm
Contact: George Pool 858-673-6840 gpool@vitaltherapies.com

Sponsors and Collaborators
Vital Therapies, Inc.
Investigators
Study Director: Jan Stange, MD Vital Therapies, Inc.
  More Information

No publications provided

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: October 14, 2013
Health Authority: 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
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 16, 2014