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:
Information provided by:
MacroGenics
ClinicalTrials.gov Identifier:
NCT01206504
First received: September 17, 2010
Last updated: July 5, 2011
Last verified: July 2011
  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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
MacroGenics
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:
Infection
Communicable Diseases
Virus Diseases
West Nile Fever
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014