Trial record 8 of 242 for:    "Expanded Access" [STUDY-TYPES]

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.
Information provided by:
MacroGenics Identifier:
First received: September 17, 2010
Last updated: July 5, 2011
Last verified: July 2011

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

Resource links provided by NLM:

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.


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

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 identifier: NCT01206504

Sponsors and Collaborators
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 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
Acute Flaccid Paralysis
Monoclonal Antibody
West Nile Neuroinvasive Disease
Accidental Exposure to West Nile Virus

Additional relevant MeSH terms:
Virus Diseases processed this record on April 17, 2014