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.

First Received on September 17, 2010. Last Updated on July 5, 2011 History of Changes

Sponsor:	MacroGenics
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	MacroGenics
ClinicalTrials.gov Identifier:	NCT01206504

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:

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:

For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis
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
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)
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 24, 2012