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Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

Primary Purpose

Acute Liver Failure

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ELAD (Extracorporeal Liver Assist System)
Sponsored by
Vital Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Liver Failure focused on measuring liver, liver failure, acute liver failure, ELAD, alcoholic hepatitis, acute on chronic hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

  • Subjects not participating in the VTI-206 clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    AOCH patients

    AAH patients

    Arm Description

    Patients with acute on chronic hepatitis

    Patients with acute alcoholic hepatitis

    Outcomes

    Primary Outcome Measures

    Gather data
    See previous description

    Secondary Outcome Measures

    Full Information

    First Posted
    October 11, 2011
    Last Updated
    December 3, 2013
    Sponsor
    Vital Therapies, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01452295
    Brief Title
    Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
    Official Title
    Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295)
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vital Therapies, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.
    Detailed Description
    Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD. The company is also collecting data related to whether a patient received a liver transplant and on survival.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Liver Failure
    Keywords
    liver, liver failure, acute liver failure, ELAD, alcoholic hepatitis, acute on chronic hepatitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AOCH patients
    Arm Type
    Experimental
    Arm Description
    Patients with acute on chronic hepatitis
    Arm Title
    AAH patients
    Arm Type
    Experimental
    Arm Description
    Patients with acute alcoholic hepatitis
    Intervention Type
    Drug
    Intervention Name(s)
    ELAD (Extracorporeal Liver Assist System)
    Intervention Description
    ELAD (Extracorporeal Liver Assist System)
    Primary Outcome Measure Information:
    Title
    Gather data
    Description
    See previous description
    Time Frame
    Five years post study participation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects participating in the VTI-206 clinical trial. Exclusion Criteria: Subjects not participating in the VTI-206 clinical trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert A Ashley
    Organizational Affiliation
    Vital Therapies, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

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