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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

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
MacroGenics
ClinicalTrials.gov Identifier:
NCT01206504
First received: September 17, 2010
Last updated: July 5, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention
West Nile Virus Infection
 Biological: MGAWN1

Study Type: Expanded Access     What is 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

Further study details as provided by MacroGenics:

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

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206504

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

No publications provided

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
Study First Received: September 17, 2010
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013