To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

February 12, 2019 updated by: Vital Therapies, Inc.

A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD® in Subjects With Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

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 and Lille score failures (Lille score >0.45).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Lille score will be used to identify subjects with an increased risk of mortality (Lille score failures). The Lille score is a prognostic model combining six reproducible variables at Day 0 and Day 7 of steroid treatment. The Lille score used in this protocol is being used independent of steroid administration during the 7 days of evaluation. A Lille score >0.45 (Lille score failure) indicates that the subject is at substantially increased risk of 30- and 90-day mortality. 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 who have failed per the Lille criteria, independent of steroid administration. ELAD treatment is done continuously for up to 10 days in addition to standard of care treatment. The Control group (those randomized 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-13353
        • Charité Campus Virchow-Klinikum Medizinische Klinik
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Cordoba, Spain, 14004
        • Hospital Reina Sofía
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain, 41014
        • Hospital Universitario de Valme
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Hospital Universitario Puerta de Hierro - Majadahonda
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital Universitario de Cruces
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Brighton & Sussex University Hospitals NHS Trust
    • England
      • London, England, United Kingdom, SE5 9RS
        • Barts Health NHS Trust
      • London, England, United Kingdom, SE59RS
        • King's College Hospital NHS Foundation Trust
    • London
      • Hampstead, London, United Kingdom, NW3 2QR
        • Royal Free Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • NHS Tayside
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • San Diego, California, United States, 92103
        • University of California San Diego
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Johns Hopkins University Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center - Twin Cities Campus
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • Rutgers University Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • Texas
      • San Antonio, Texas, United States, 78215
        • University of Texas Health Science Center, San Antonio
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 ;
  • Total bilirubin ≥8 mg/dL;
  • Medical history of alcohol abuse with evidence of a causal and temporal (<6 weeks) relationship to the use of alcohol and hospital admission for this episode of sAAH;
  • Maddrey score ≥32
  • A clinical diagnosis of severe acute alcoholic hepatitis (sAAH);
  • Subject must have liver biopsy or in investigator's opinion, if risk is too great to perform liver biopsy, then clinical diagnosis is sufficient;
  • Subject must be a Lille score failure (Lille score >0.45) as defined in this study.

Exclusion Criteria:

  • Platelet count <50,000/mm3;
  • International Normalization Ratio (INR) >3.0;
  • MELD score >35;
  • Evidence of infection unresponsive to antibiotics;
  • Evidence of jaundice for >3 months;
  • Hospital admission for any episodes of liver decompensation not related to sAAH, (other than this episode of sAAH) within the past 2 months;
  • Evidence of hemodynamic instability;
  • Evidence of active bleeding or of major hemorrhage defined as requiring ≥2 units of packed red blood cells to maintain a stable hemoglobin occurring within 48 hours of Screening;
  • Evidence of occlusive portal vein thrombosis impairing hepatopetal flow, 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;
  • Clinical evidence of liver size reduction due to cirrhosis, unless Investigator interpretation of the clinical evidence indicates liver size of <10 cm or volume of <750 cc is not considered reduced for the individual subject;
  • 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 as determined by β-human chorionic gonadotropin (HCG) results;
  • Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies (the observational study setting should not affect the safety and/or efficacy of the VTI-210 clinical trial);
  • Currently listed or scheduled for liver transplant during the 90-day study period;
  • Previous liver transplant;
  • Previous participation in a clinical trial involving ELAD;
  • 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 (the DNR/DNI criterion is not applicable in the UK);
  • Refusal to participate in the VTI-210E follow-up study;
  • Is unable to provide an address for follow-up home visits.

And other inclusion/exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ELAD (plus Standard of Care)
ELAD is a human cell-based bio-artificial liver support system developed to improve survival of patients with acute liver failure and to provide liver support continuously to a subject with compromised liver function. 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 draws blood from the subject via a dual-lumen catheter placed in a large vein, and then separates the plasma fluid (ultrafiltrate) from cellular components using a specifically-designed ultrafiltrate generator cartridge. While the cellular components are returned to the subject via the venous access, the ultrafiltrate is circulated at a high flow rate through the four metabolically-active ELAD cartridges which contain cloned, immortalized human hepatoblastoma cells (VTL C3A cells) derived from a subclone of the human hepatoblastoma cell line HepG2.
Other Names:
  • Human Cell-Based Bio-Artificial Liver Support System
Other: Standard of Care treatment
Standard of care treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Other Names:
  • Usual treatment for the disease
Other: 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 treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
Other Names:
  • Usual treatment for the disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months
The primary endpoint of the study was a comparison of overall survival (OS) between ELAD-treated and Control groups, with protocol VTI-210E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (11 July 2016).
Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Survivors at Study Day 91.
Time Frame: Up to Study Day 91.
Assess the proportion of survivors at Study Day 91.
Up to Study Day 91.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vital Therapies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajiv Jalan, MD, UK - Royal Free Hospital
  • Principal Investigator: José Luis Montero, MD, Spain - Hospital Reina Sofia
  • Principal Investigator: Rafael Bañares, MD, Spain - Hospital Gregorio Marañon
  • Principal Investigator: Valentin Cuervas-Mons Martinez, MD, Spain - Hospital Universitario Puerta de Hierro - Majadahonda
  • Principal Investigator: Santiago Tome, MD, Spain - Hospital Clinico Universitario de Santiago de Compostela
  • Principal Investigator: Martín Prieto, MD, Spain - Hospital Universitario y Politécnico La Fe
  • Principal Investigator: Sumita Verma, MD, UK - Brighton & Sussex University Hospitals NHS Trust
  • Principal Investigator: Paul J Gaglio, MD, NY - Montefiore Medical Center
  • Principal Investigator: Manuel Romero-Gomez, MD, Spain - Hospital Universitario de Valme
  • Principal Investigator: Andrew deLemos, MD, NC - Carolinas Medical Center
  • Principal Investigator: Joanna Sayer, MD, UK - Doncaster Royal Infirmary
  • Principal Investigator: Javier Crespo, MD, Spain - Hospital Universitario Marques de Valdecilla
  • Principal Investigator: David Reich, MD, PA - Drexel University College of Medicine
  • Principal Investigator: Anne M Larson, MD, WA - Swedish Medical Center
  • Principal Investigator: Xaralambos Zervos, DO, FL - Cleveland Clinic Florida
  • Principal Investigator: Kirti Shetty, MD, MD - Johns Hopkins University Hospital
  • Principal Investigator: Alexander Kuo, MD, CA - University of California San Diego
  • Principal Investigator: Maria Jesús Suárez, MD, Spain - Hospital Universitario de Cruces
  • Principal Investigator: Nikolaos T Pyrsopoulos, MD, NJ - Rutgers University Hospital
  • Principal Investigator: Julio Gutierrez, MD, TX - University of Texas Health Science Center, San Antonio
  • Principal Investigator: Agustín Albillos, MD, Spain - Hospital Universitario Ramón y Cajal
  • Principal Investigator: Anupama Duddempudi, MD, NY - North Shore University Hospital
  • Principal Investigator: Marco Antonio Olivera-Martinez, MD, NE - University of Nebraska Medical Center
  • Principal Investigator: Eckart Schott, MD, Germany - Charité Campus Virchow-Klinikum Medizinische Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VTI-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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