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Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

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ClinicalTrials.gov Identifier: NCT02612428
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.

Brief Summary:

The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.

The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.


Condition or disease Intervention/treatment Phase
Acute Alcoholic Hepatitis Biological: ELAD System Other: Standard of Care (Control) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects With Alcohol-Induced Liver Decompensation (AILD)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: ELAD System
This group will receive treatment with ELAD plus standard of care therapy.
Biological: ELAD System
An extracorporeal human hepatic cell-based liver treatment
Other Name: ELAD
Standard of Care (Control)
This group will receive standard of care therapy as defined in the protocol.
Other: Standard of Care (Control)
Standard medical treatment as defined by the protocol
Other Name: Standard of Care



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 91 days ]
    Overall survival will be assessed using a Kaplan-Meier analysis of the Intent-to-Treat population, utilizing a log-rank test


Secondary Outcome Measures :
  1. Proportion of survivors [ Time Frame: 91 days ]
    A chi-square test will be used to evaluate the proportion of subjects who survived at end of study day 91



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet ALL inclusion criteria to be eligible for the study:

  1. Age ≥18;
  2. Total bilirubin ≥16 mg/dL (≥273.6 µmol/L);
  3. A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon lab test or medical history or family interview with a causal relationship and temporal association (6 weeks or less) of alcohol use and hospital admission for this episode of AILD;
  4. Maddrey score ≥32;
  5. Subjects must have AILD that is severe acute alcoholic hepatitis (sAAH) diagnosed with either:

    a. A confirmatory liver biopsy, OR b. Two or more of the following: i. Hepatomegaly, ii. AST > ALT, iii. Ascites, iv. Leukocytosis (WBC count above lab normal at site);

    Note: Subjects will be classified as either:

    1. AILD that is sAAH with no underlying liver disease other than alcoholic liver disease, OR
    2. AILD that is sAAH with evidence of underlying liver disease other than alcoholic liver disease which must be documented by:

    i. Liver biopsy, AND/OR ii. Laboratory findings, AND/OR iii. Medical history;

  6. Not eligible for liver transplant during this hospitalization;
  7. Subject or legally-authorized representative must provide Informed Consent;
  8. Subject must be eligible for Standard of Care treatment as defined in the protocol.

Exclusion Criteria:

Subjects must NOT have any of the exclusion criteria to be eligible for the study:

  1. Age ≥50;
  2. Platelet count <40,000/mm3;
  3. International Normalization Ratio (INR) >2.5;
  4. Serum Creatinine ≥1.3 mg/dL (≥115.04 µmol/L);
  5. MELD score ≥30;
  6. AST >500 IU/L;
  7. Evidence of infection unresponsive to antibiotics (e.g. increased tissue involvement relative to initial diagnosis, clinical worsening of symptoms, etc.) indicated by any of the following:

    1. Presence of sepsis or septic shock; OR
    2. Positive blood cultures (bacteremia, fungemia) within 72 hours prior to Randomization; OR
    3. Presence of spontaneous bacterial peritonitis during the 2 days prior to Randomization; OR
    4. Clinical and radiological signs of pneumonia;
  8. Evidence of reduction in total bilirubin of 20% or more in the previous 72 hours. Bilirubin measurements must be taken at least 12 hours after any procedure known to artificially alter serum bilirubin (e.g., administration of packed red blood cells, plasma exchange);
  9. Evidence of hemodynamic instability as defined by the following:

    1. Systolic blood pressure <90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
    2. Mean arterial pressure (MAP) <60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
    3. Requirement for escalating doses of vasopressor support prior to Screening; OR
    4. Subject on vasopressors, including but not limited to those listed below, at doses above the following at Screening or Randomization:

      • Dobutamine: 5.0 µg/kg/min
      • Dopamine: 2.0 µg/kg/min
      • Norepinephrine: 0.02 µg/kg/min
      • Phenylephrine: 1.0 µg/kg/min
      • Vasopressin: 0.02 U/min
  10. Evidence of active bleeding, major hemorrhage defined as requiring ≥2 units packed red blood cells to maintain a stable hemoglobin occurring within 48 hours prior to Randomization, or with banding of gastroesophageal varices during the 7 days immediately preceding screening;
  11. Clinical evidence of liver size reduction due to cirrhosis [liver size of the craniocaudal diameter (sagittal view) <10 cm when measured on the mid clavicular line (or equivalent measurement) by ultrasound, or liver volume <1200 cc as determined by CT or MRI], unless Investigator interpretation of the clinical evidence indicates liver size of <10 cm or volume <1200 cc is not considered reduced for the individual subject, and Sponsor agrees;
  12. Occlusive portal vein thrombosis impairing hepatopetal flow, or evidence of bile duct obstruction;
  13. Evidence by physical exam, history, or laboratory evaluation, of significant concomitant disease with a life expectancy of less than 3 months, including, but not limited to:

    1. Severe acute or chronic cardiovascular, central nervous system, or pulmonary disease;
    2. Cancer that has metastasized or has not yet been treated;
    3. Severe metabolic abnormalities that have not been corrected (See Section 5.1.3);
  14. Subject has chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
  15. Subject ventilated or intubated;
  16. Subject on hemodialysis;
  17. Subject has liver disease related to homozygous hemachromotosis, Wilson's disease, has non-alcoholic fatty liver disease, or Budd-Chiari Syndrome;
  18. Serological evidence (including viral titers) of active viral hepatitis A, B or C infection. If the investigator suspects that the subject may be at risk for viral hepatitis A, B or C, and no serology is available, then serologies must be obtained prior to Randomization, as a positive serology would be exclusionary;
  19. Pregnancy as determined by serum β-human chorionic gonadotropin (HCG) results, or subjects of child-bearing potential not willing to use effective means of contraception, without history of medical or surgical sterilization;
  20. 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 VTL-308 clinical trial);
  21. Previous liver transplant;
  22. Previous enrollment in the treatment phase of another ELAD trial;
  23. Have a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or such local equivalent) or any other Advanced Directive limiting Standard of Care in place (the DNR/DNI criterion is not applicable in Europe);
  24. Refusal to participate in the VTL-308E follow-up study;
  25. Inability to provide an address for home visits.

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): NCT02612428


Contacts
Contact: Michael Stephens, PhD 858-924-1991 mstephens@vitaltherapies.com
Contact: Brian Dempster 858-649-1814 bdempster@vitaltherapies.com

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Andres Duarte-Rojo, MD    501-686-5177    aduarterojo@uams.edu   
Contact: Mauricio Garcia Saenz de Sicilia, MD    (501) 686-5177    mgarcia@uams.edu   
Principal Investigator: Andres Duarte-Rojo, MD         
United States, California
Sharp Coronado Hospital Recruiting
Coronado, California, United States, 92118
Contact: Tarek Hassanein, MD    619-522-0330      
Principal Investigator: Tarek Hassanein, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Waldo Concepcion, MD    650-723-5454    WConcepcion@stanfordhealthcare.org   
Contact: Radhika Kumari, MD    909-728-7113    rkumari@stanford.edu   
Principal Investigator: Waldo Concepcion, MD         
United States, Florida
Schiff Center for Liver Diseases/University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Andrea Elibero, RN BSN CCRC    305-243-6968    axe375@med.miami.edu   
Contact: Kaylan R Bhamidimarri, MD MPH    305-243-3333    KBhamidimarri@med.miami.edu   
Principal Investigator: Kaylan R Bhamidimarri, MD MPH         
United States, Georgia
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Bethany Lane, RN,MSN,CCRC    404-605-4618    bethany.lane@piedmont.org   
Contact: Joy Burnette, RN,BSN,CRC    404-605-3212    joy.burnette@piedmont.org   
Principal Investigator: Lance Stein, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ram Subramanian, MD    404-712-1816    rmsubra@emory.edu   
Contact: Donna Kang, RN, BSN    404-712-4260    Donna.Lee.Kang@emory.edu   
Principal Investigator: Ram Subramanian, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Diana Giczewski, RN, MS, BSN    312-563-3919    Diana_Giczewski@rush.edu   
Contact: Lelani Fetrow    312-942-1372    Lelani_C_Fetrow@rush.edu   
Principal Investigator: Nikunj Shah, MD         
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Sung Cho    410-576-5389    scho@mdmercy.com   
Principal Investigator: Paul Thuluvath, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Raza Malik, MD    617-632-1070      
Contact: Susan McDermott, MPH, RN    617-632-9841      
Principal Investigator: Raza Malik, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Scott Rajala    612-626-8511    srajala@umn.edu   
Contact: Julie Thompson, MD       thom0235@umn.edu   
Principal Investigator: Julie Thompson, MD         
United States, Missouri
University of Missouri Hospital Recruiting
Columbia, Missouri, United States, 65212
Contact: Syed Naqvi, MD    573-884-9075      
Principal Investigator: Syed Naqvi, MD         
United States, New Jersey
Rutgers University Hospital Recruiting
Newark, New Jersey, United States, 07101
Contact: Nikolaos Pyrsopoulos, MD    973-972-5252    pyrsopni@njms.rutgers.edu   
Contact: Serban A Moroianu    973-972-0130    moroiasa@njms.rutgers.edu   
Principal Investigator: Nikolaos Pyrsopoulos, MD         
United States, New York
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Kristina Chacko, MD    718-920-7561    krchacko@montefiore.org   
Contact: Alana Zanetti-Yabur       alana.zanetti-yabur@einstein.yu.edu   
Principal Investigator: Kristina Chacko, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Cynthia Wiley-Wade    216-444-2084    wileywc@ccf.org   
Contact: Margaret Terry    216-445-4790    terrym@ccf.org   
Principal Investigator: Talal Adhami, MD         
United States, Pennsylvania
The Pennsylvania State University and The Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Karen Krok, MD    717-531-1017    KKrok@pennstatehealth.psu.edu   
Contact: Laurie Peiffer, RCC    717-531-5226    lpeiffer@pennstatehealth.psu.edu   
Principal Investigator: Karen Krok, MD         
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Cynthia Gifford-Hollingsworth, DrNP, CRNP    267-507-6811    Cgiffor1@drexelmed.edu   
Contact: David Reich, MD    215-762-3900    david.reich@drexelmed.edu   
Principal Investigator: David Reich, MD         
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Marva James, RN,MHS,CCRN    215-456-2004    JamesMar@einstein.edu   
Contact: Stacey Carmody    215-456-7534    CarmodyS@einstein.edu   
Principal Investigator: Simona Rossi, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Mary Kruth, RN CRC    412-647-3855    kruthm@upmc.edu   
Contact: Mary Stefanick, RN BSN CCRC    412-802-6746    stefanickma@upmc.edu   
Principal Investigator: Ali Al-Khafaji, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Constance Mobley, MD, PhD    713-441-1590    cmmobley@houstonmethodist.org   
Contact: Melissa Whipple, RN    713-441-3247    mbwhipple@houstonmethodist.org   
Principal Investigator: Constance Mobley, MD, PhD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jaye Davis, RN    434-924-1784    jbd3g@eservices.virginia.edu   
Contact: Jennifer A Greene, RN BSN CCRC    434-982-0709    JAG7FH@hscmail.mcc.virginia.edu   
Principal Investigator: Stephen Caldwell, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Lynda Yanny, RN BSN CCRC    414-649-6685    lynda.yanny@aurora.org   
Contact: Mary Briggs-Sedlachek, RN    414-219-4873    mary.briggs-sedlachek@aurora.org   
Principal Investigator: David J Kramer, MD         
Austria
Medizinische Universität Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Rudolf Stauber, MD    +43-316-385-80268    rudolf.stauber@medunigraz.at   
Principal Investigator: Rudolf Stauber, MD         
Medizinische Universität Klinik Für Innere Medizin III Recruiting
Vienna, Austria, 1090
Contact: Christian Zauner, MD    +43 1 40400 47670    christian.zauner@meduniwien.ac.at   
Contact: Monika Schmid    +43 1 40400 47670    monika.schmid@meduniwien.ac.at   
Principal Investigator: Christian Zauner, MD         
Germany
Klinikum Landshut gemeinnuetzige GmbH Recruiting
Landshut, Bavaria, Germany, 84034
Contact: Matthias Dollinger, MD, PhD    +49 (0)871 698 3717    matthias.dollinger@klinikum-landshut.de   
Principal Investigator: Matthias Dollinger, MD, PhD         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, D-30625
Contact: Markus Busch, MD    +49 511 532 7623    busch.markus@mh-hannover.de   
Contact: Hans Heinrich Wedemeyer, MD    +49 511 532 6814    wedemeyer.heiner@mh-hannover.de   
Principal Investigator: Markus Busch, MD         
Universitätsmedizin Mainz Recruiting
Mainz, Germany, 55131
Contact: Oliver Schreiner, MD    06131 17-2613/17-7103    Oliver.Schreiner@unimedizin-mainz.de   
Contact: Peter R Galle, MD    06131 17-2613/17-6831    Peter.Galle@unimedizin-mainz.de   
Principal Investigator: Peter R Galle, MD         
Universitätsklinikum Münster Recruiting
Münster, Germany, D-48149
Contact: Christian Wilms, MD    +49 251 83 57935    christian.wilms@ukmuenster.de   
Contact: Hartmut Schmidt, MD    +49 251 83 57935    hepar@ukmuenster.de   
Principal Investigator: Hartmut Schmidt, MD         
Universitätsmedizin Rostock Recruiting
Rostock, Germany, D-18065
Contact: Georg Lamprecht, MD    +49 381 494 7481    Georg.Lamprecht@med.uni-rostock.de   
Principal Investigator: Georg Lamprecht, MD         
Ireland
Belfast Health and Social Care Trust Recruiting
Belfast, Ireland, BT9 7AB
Contact    0044 (0) 28 9024 0503      
Contact    www.belfasttrust.hscni.net      
St. Vincent's University Hospital Recruiting
Dublin, Ireland, Dublin 4
Contact    00353 1 2214117      
Contact    www.stvincents.ie      
Spain
Hospital Puerta de Hierro Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Valentin Cuervas-Mons, MD    +34911917341    valentin.cuervasmons@uam.es   
Principal Investigator: Valentin Cuervas-Mons, MD         
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Juan Caballeria, MD    +34 93 227 57 53    CABALLER@clinic.cat   
Principal Investigator: Juan Caballeria, MD         
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Rafael Bañares, MD    +34 91 586 83 08    rafael.banares@salud.madrid.org   
Principal Investigator: Rafael Bañares, MD         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Manuel Romero-Gomez, MD    +34 600 162 875    mromerog@gmail.com   
Principal Investigator: Manuel Romero-Gomez, MD         
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain, 46026
Contact: Martin Prieto Castillo, MD    +34 961 245 859    mprietoc@gmail.com   
Principal Investigator: Martin Prieto Castillo, MD         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Contact: Trinidad Serrano Aullo, MD    +34 976 55 64 00 ext 162454    tserrano.aullo@gmail.com   
Principal Investigator: Trinidad Serrano Aullo, MD         
United Kingdom
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L97AL
Contact    01515255980      
Contact    www.aintreehospital.nhs.uk      
Ninewells Hospital and Medical School Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact    01382 660111      
Contact: www.nhstayside.scot.nhs.uk         
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G40SF
Contact    0141 211 4000      
Contact    www.nhsggc.org.uk      
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2GW
Contact    0121 627 2000      
Contact    www.@uhb.nhs.uk      
Doncaster Royal Infirmary Recruiting
Doncaster, United Kingdom, DN2 5LT
Contact    01302 366666      
Contact    www.dbh.nhs.uk      
Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact    +44 20 3594 6773      
Contact    www.bartshealth.nhs.uk      
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact    020 7794 0500      
Contact    www.@ucl.ac.uk      
Nottingham University Hospital Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact    0115 924 9924      
Contact    www.nuhrise.org      
Sponsors and Collaborators
Vital Therapies, Inc.
Investigators
Study Director: Jan Stange, MD Vital Therapies, Inc.
Principal Investigator: David Reich, MD PA - Drexel University
Principal Investigator: Lance Stein, MD GA - Piedmont Atlanta Hospital
Principal Investigator: Nikolaos Pyrsopoulos, MD NJ - Rutgers University Hospital
Principal Investigator: Valentin Cuervas-Mons, MD Spain - Hospital Universitario Puerta de Hierro Majadahonda
Principal Investigator: Raza Malik, MD MA - Beth Israel Deaconess Medical Center
Principal Investigator: Nikunj Shah, MD IL - Rush University Medical Center
Principal Investigator: Simona Rossi, MD PA - Albert Einstein Medical Center
Principal Investigator: Juan Caballeria, MD Spain - Hospital Clinic de Barcelona
Principal Investigator: Ram Subramanian, MD GA - Emory University Hospital
Principal Investigator: Andres Duarte-Rojo, MD AR - University of Arkansas for Medical Sciences
Principal Investigator: Julie Thompson, MD MN - University of Minnesota
Principal Investigator: Peter R Galle, MD Germany - Universitätsmedizin Mainz
Principal Investigator: Hartmut H.-J. Schmidt, MD Germany - Universitätsklinikum Münster
Principal Investigator: Markus Busch, MD Germany - Medizinische Hochschule Hannover
Principal Investigator: Kristina Chacko, MD NY - Montefiore Medical Center
Principal Investigator: Talal Adhami, MD OH - Cleveland Clinic Foundation
Principal Investigator: Constance Mobley, MD, PhD TX - Houston Methodist Hospital
Principal Investigator: David J Kramer, MD WI - Aurora St. Luke's Medical Center
Principal Investigator: Stephen Caldwell, MD VA - University of Virginia Health System
Principal Investigator: Ali Al-Khafaji, MD PA - University of Pittsburgh Medical Center
Principal Investigator: Kalyan R Bhamidimarri, MD FL - Schiff Center for Liver Diseases/University of Miami
Principal Investigator: Manuel Romero-Gomez, MD Spain - Hospital Universitario Virgen del Rocío
Principal Investigator: Tarek Hassanein, MD CA - Sharp Coronado Hospital
Principal Investigator: Waldo Concepcion, MD CA - Stanford University Medical Center
Principal Investigator: Martin Prieto Castillo, MD Spain - Hospital Universitario y Politécnico La Fe
Principal Investigator: Rafael Bañares, MD Spain - Hospital Universitario Gregorio Marañón
Principal Investigator: Syed Naqvi, MD MO - University of Missouri Hospital
Principal Investigator: Matthias Dollinger, MD, PhD Germany - Klinikum Landshut gemeinnuetzige GmbH
Principal Investigator: Karen Krok, MD PA - The Pennsylvania State University and The Milton S. Hershey Medical Center
Principal Investigator: Rudolf Stauber, MD Austria - Medizinische Universität Graz
Principal Investigator: Christian Zauner, MD Austria - Medizinische Universität Klinik Für Innere Medizin III
Principal Investigator: Georg Lamprecht, MD Germany - Universitätsmedizin Rostock
Principal Investigator: Paul Thuluvath, MD MD - Mercy Medical Center
Principal Investigator: Trinidad Serrano Aullo, MD Spain - Hospital Clínico Universitario Lozano Blesa

Additional Information:
Responsible Party: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02612428     History of Changes
Other Study ID Numbers: VTL-308
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders