Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure

MacroGenics

Status

Conditions: West Nile Virus Infection

Treatments: Biological: MGAWN1

Study type: Expanded Access

Funder types: Industry; NIH

Identifiers

NCT01206504

CP-MGAWN1-EA1

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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