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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

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ClinicalTrials.gov Identifier: NCT01206504
Recruitment Status : No longer available
First Posted : September 22, 2010
Last Update Posted : July 6, 2011
Information provided by:

Study Description
Brief Summary:
This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.

Condition or disease Intervention/treatment
West Nile Virus Infection Biological: MGAWN1

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.

Study Design

Study Type : Expanded Access
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Biological: MGAWN1
    Humanized monoclonal to West Nile virus. Dose=30mg/kg
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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
Contacts and Locations

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): NCT01206504

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Anastasia Daifotis, M.D. MacroGenics
More Information

Responsible Party: Stanley Pillemer, M.D., Vice President of Clinical Research, MacroGenics, Inc
ClinicalTrials.gov Identifier: NCT01206504     History of Changes
Other Study ID Numbers: CP-MGAWN1-EA1
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by MacroGenics:
West Nile virus
Acute Flaccid Paralysis
Monoclonal Antibody
West Nile Neuroinvasive Disease
Accidental Exposure to West Nile Virus

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
West Nile Fever
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections