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NCT00068055 · ClinicalTrials.gov registry record · Phase 1
IVIG - West Nile Encephalitis: Safety and Efficacy
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT00068055 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 62 participants.
The verdict
NCT00068055, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will look at the safety and effectiveness of an experimental medication containing antibodies (Omr-IgG-am™) in people with West Nile Virus (WNV) who already have brain and/or spinal cord inflammation or who are at high risk of developing these problems because they have weak immune systems. WNV can cause problems such as headaches, fever, muscle weakness, coma, and death. Study investigators believe people who are not able to fight infection well may be at risk for developing neurologic problems (having to do with the brain, spinal cord, nerves, and muscles) if they get WNV infection. Up to 110 subjects, 18 years or older, will participate for about 3 months and will receive either Omr-IgG-am™, Polygam® S/D, or placebo given through a small tube placed in a blood vessel in the arm. Hospitalization, up to 5 additional study visits, blood sample collection, MRI pictures of the brain and spinal cord, and neurological, muscle, and heart activity tests are also required.
Interventions
- DRUG Placebo
- DRUG Omr-lgG-am
- DRUG Polygam® S/D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2003-09 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00068055
The ClinicalTrials.gov registry entry for NCT00068055 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00068055 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00068055 about?
NCT00068055 is a clinical study titled "IVIG - West Nile Encephalitis: Safety and Efficacy". This study will look at the safety and effectiveness of an experimental medication containing antibodies (Omr-IgG-am™) in people with West Nile Virus (WNV) who already have brain and/or spinal cord inflammation or who are at high risk of developing these problems because they have weak immune system...
What is the current status of trial NCT00068055?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2003-09. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00068055?
The interventions under investigation include: Placebo (DRUG), Omr-lgG-am (DRUG), Polygam® S/D (DRUG).
Who is sponsoring clinical trial NCT00068055?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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