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NCT00069316 · ClinicalTrials.gov registry record · Phase 2
Omr-IgG-am(Trademark) for Treating Patients With or at High Risk for West Nile Virus Disease
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00069316 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 2 participants.
The verdict
NCT00069316, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg) containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in patients with suspected or laboratory diagnosed WNV disease. An initial estimation of efficacy will also be made. This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West Nile encephalitis and/or myelitis or those with a positive laboratory test for diagnosis of WNV infection who are at high risk for progressing to severe neurologic disease based on age or immunosuppression. Patients will be randomized in blocks of five to receive either Omr-IgG-am(Trademark), Polygam(Registered Trademark) S/D (IVIG containing minimal anti-WNV antibodies) or normal saline in a ratio of 3:1:1. Patients and investigators will be blinded to treatment assignments. Patients will receive a single intravenous dose of study medication or one of two placebos. The study participants will receive 0.5 grams/kg of Omr-IgG-am(Trademark) or Polygam(Registered Trademark) S/D or a comparable volume of normal saline. All patients will be followed for safety, natural history endpoints, and efficacy. A subset of patients will have pharmacokinetic measurements of specific anti- WNV antibodies assessed following treatment. The primary endpoints are safety and tolerability following Omr-IgG-am(Trademark) administration. Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in confirmed WNV positive patients, and the combination of mortality and functional status at three months in both confirmed WNV-infected patients and all patients by intention to treat. This combined endpoint will be measured using four standardized measures of cognitive and functional status: the Barthel Index; the Modified Rankin Scale; the Glasgow Outcome Score; and the Modified Mini-Mental Status Examination. A comparison of outcomes will be made for the group receiving Omr-IgG-am(T
Interventions
- DRUG Omr-IgG-am
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2003-09-22 |
| Est. Completion | 2007-06-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069316
The ClinicalTrials.gov registry entry for NCT00069316 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omr-IgG-am is the first listed.
NCT00069316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069316 about?
NCT00069316 is a clinical study titled "Omr-IgG-am(Trademark) for Treating Patients With or at High Risk for West Nile Virus Disease". Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg) containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in patients with suspected or laboratory diagnosed WNV disease. An initial estimation of efficacy will also be made. Thi...
What is the current status of trial NCT00069316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2003-09-22. Estimated completion is 2007-06-27.
What interventions are being tested in trial NCT00069316?
The interventions under investigation include: Omr-IgG-am (DRUG).
Who is sponsoring clinical trial NCT00069316?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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