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Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure

Primary Purpose

West Nile Virus Infection

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
MGAWN1
Sponsored by
MacroGenics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for West Nile Virus Infection focused on measuring West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Neuroinvasive Disease, Accidental Exposure to West Nile Virus

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis

  2. For immunocompromised subjects with suspected West Nile virus infection:

    • Receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or
    • Have received organs or tissues or cells from donors likely infected with West Nile virus (as shown by serology or PCR/NAT from the donor, organs, or tissues) or
    • Have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency
  3. For subjects with substantial exposure to West Nile virus: Exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident)
  4. Develop signs and/or symptoms within 14 days before study enrollment

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 17, 2010
    Last Updated
    February 4, 2022
    Sponsor
    MacroGenics
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01206504
    Brief Title
    Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
    Official Title
    Expanded Access to MGAWN1 in Subjects With: Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection and a Compromised Immune System; or Substantial Accidental Exposure to West Nile Virus
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    No longer 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
    MacroGenics
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    5. Study Description

    Brief Summary
    This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.
    Detailed Description
    The objective of this study is to provide expanded access to MGAWN1; the study is not intended for subjects who are eligible for and have access to non-expanded access protocols.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    West Nile Virus Infection
    Keywords
    West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Neuroinvasive Disease, Accidental Exposure to West Nile Virus

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    MGAWN1
    Intervention Description
    Humanized monoclonal to West Nile virus. Dose=30mg/kg

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Eligibility Criteria
    Inclusion Criteria: For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis For immunocompromised subjects with suspected West Nile virus infection: Receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or Have received organs or tissues or cells from donors likely infected with West Nile virus (as shown by serology or PCR/NAT from the donor, organs, or tissues) or Have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency For subjects with substantial exposure to West Nile virus: Exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident) Develop signs and/or symptoms within 14 days before study enrollment

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure

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