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

Overview

This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.

Full Title of Study: “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

  • Study Type: Expanded Access

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.

Interventions

  • Biological: MGAWN1
    • Humanized monoclonal to West Nile virus. Dose=30mg/kg

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 8 Years

    Maximum Age: N/A

    Investigator Details

    • Lead Sponsor
      • MacroGenics
    • Collaborator
      • National Institute of Allergy and Infectious Diseases (NIAID)
    • Provider of Information About this Clinical Study
      • Stanley Pillemer, M.D., Vice President of Clinical Research, MacroGenics, Inc
    • Overall Official(s)
      • Anastasia Daifotis, M.D., Study Director, MacroGenics

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