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

NCT01206504 | Unknown

• 1 other identifier: CP-MGAWN1-EA1
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

West Nile Virus Infection

Keywords

West Nile virus; WNV; Encephalitis; Meningitis; Acute Flaccid Paralysis; Monoclonal Antibody; WNND; West Nile Neuroinvasive Disease; Accidental Exposure to West Nile Virus

Interventions

MGAWN1 BIOLOGICAL

Humanized monoclonal to West Nile virus. Dose=30mg/kg

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• MacroGenics: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

West Nile Fever; Encephalitis; Meningitis; acute flaccid myelitis

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 22, 2010
• Last Updated: February 22, 2022

Record last verified: 2022-01