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

NCT ID: NCT01206504

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Detailed Description

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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.

Conditions

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West Nile Virus Infection

Interventions

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MGAWN1

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

MacroGenics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CP-MGAWN1-EA1

Identifier Type: -

Identifier Source: org_study_id

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