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

• Conditions: West Nile Virus Infection

• Registration Number: NCT01206504
• Lead Sponsor: MacroGenics

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified