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Expanded Access to Elezanumab

Primary Purpose

Acute Spinal Cord Injury (SCI), Acute Ischemic Stroke

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Elezanumab
Sponsored by
AbbVie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Acute Spinal Cord Injury (SCI) focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

Eligibility Criteria

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

Inclusion Criteria:

  • The participant must not be eligible for an elezanumab clinical trial.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 18, 2020
    Last Updated
    April 10, 2023
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04278235
    Brief Title
    Expanded Access to Elezanumab
    Official Title
    Expanded Access to Elezanumab
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Spinal Cord Injury (SCI), Acute Ischemic Stroke
    Keywords
    Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Elezanumab
    Other Intervention Name(s)
    ABT-555
    Intervention Description
    Solution for intravenous (IV) infusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - The participant must not be eligible for an elezanumab clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ABBVIE CALL CENTER
    Phone
    844-663-3742
    Email
    abbvieclinicaltrials@abbvie.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ABBVIE INC.
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Elezanumab

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