West Nile Virus InfectionNCT01206504
Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
A study testing MGAWN1 in people with West Nile Virus Infection, run by MacroGenics.
Trial summary
This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- West Nile Virus Infection
- What is being tested?
- MGAWN1
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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
This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.
Read the 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.
- Conditions
- West Nile Virus Infection
- Being tested
- MGAWN1
- Keywords
- West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Neuroinvasive Disease, Accidental Exposure to West Nile Virus
- Medical subject headings
- West Nile Fever, Encephalitis, Meningitis, acute flaccid myelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGAWN1Biological
Humanized monoclonal to West Nile virus. Dose=30mg/kg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for West Nile Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206504
- Sponsor's protocol ID
- CP-MGAWN1-EA1
- Status last verified
- Jan 2022
- First submitted
- 17 Sep 2010
- Last updated
- 22 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01206504
- Acronym / sponsor ID
- CP-MGAWN1-EA1
- Conditions
- West Nile Virus Infection
- Keywords
- West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Neuroinvasive Disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGAWN1Humanized monoclonal to West Nile virus. Dose=30mg/kg | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MGAWN1 in people with West Nile Virus Infection, run by MacroGenics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.