Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
Primary Purpose
West Nile Virus Infection
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
MGAWN1
Sponsored by
About this trial
This is an expanded access trial for West Nile Virus Infection focused on measuring West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Neuroinvasive Disease, Accidental Exposure to West Nile Virus
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01206504
First Posted
September 17, 2010
Last Updated
February 4, 2022
Sponsor
MacroGenics
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT01206504
Brief Title
Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MGAWN1
Intervention Description
Humanized monoclonal to West Nile virus. Dose=30mg/kg
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
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