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

West Nile Virus Infection Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01206504
• Other study ID #: CP-MGAWN1-EA1
• Status: No longer available

Study information

• Verified date: January 2022
• Source: MacroGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Virus Diseases
• West Nile Fever
• West Nile Virus Infection

Intervention

Biological:
• MGAWN1
Humanized monoclonal to West Nile virus. Dose=30mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MacroGenics	National Institute of Allergy and Infectious Diseases (NIAID)