IVIG - West Nile Encephalitis: Safety and Efficacy
Public ClinicalTrials.gov record NCT00068055. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Intravenous Immunoglobulin G (OMR-IGG-AM) Containing High Anti-West Nile Virus Antibody Titers in Patients With, or at High Risk for Progression to West Nile Virus (WNV) Encephalitis and/or Myelitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00068055
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2003 (Type not available)
- Primary completion
- Dec 2006 (Actual)
- Completion
- Dec 2006 (Actual)
- Last update posted
- Feb 7, 2011
2003 – 2006
United States locations
- U.S. sites
- 66
- U.S. states
- 29
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-2050 | — |
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | — |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| University of Arizona Health Sciences Center | Tucson | Arizona | 85724 | — |
| University of Arkansas | Little Rock | Arkansas | 72205 | — |
| Enloe Medical Center | Chico | California | 95926 | — |
| Seton Medical Center | Daly City | California | 94015 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Kaiser Permanente South Bay Medical Center | Harbor City | California | 90710 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California Irvine | Orange | California | 92868-3298 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of California San Francisco | San Francisco | California | 94114 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Santa Rosa Kaiser Medical | Santa Rosa | California | 95403 | — |
| Exempla St. Joseph Hospital | Denver | Colorado | 80218 | — |
| University of Colorado | Denver | Colorado | 80262 | — |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | — |
| Idaho Falls Infectious Diseases, PLLC | Idaho Falls | Idaho | 83404 | — |
| Loyola University | Maywood | Illinois | 60153 | — |
| Indiana University | Indianapolis | Indiana | 46202-5124 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| University of Kentucky | Lexington | Kentucky | 40536-0084 | — |
| Tulane University | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| National Institutes of Health | Bethesda | Maryland | 20892-1662 | — |
| University of Michigan | Ann Arbor | Michigan | 48105 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110-1093 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Mercury Street Medical Group | Butte | Montana | 59701 | — |
| Infectious Disease Specialists, PC | Missoula | Montana | 59802 | — |
| Central Nebraska Medical Clinic | Broken Bow | Nebraska | 68822 | — |
| McCook Clinic, PC | McCook | Nebraska | 69001 | — |
| Great Plains Regional Medical Center | North Platte | Nebraska | 69101 | — |
| VA Medical Center - Omaha | Omaha | Nebraska | 68105 | — |
| Creighton University | Omaha | Nebraska | 68131 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7630 | — |
| Clara Maass Medical Center | Belleville | New Jersey | 07109 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| Flushing Hospital Medical Center | Flushing | New York | 11355 | — |
| St. Alexius Medical Center | Bismarck | North Dakota | 58506 | — |
| Dakota Clinic at Innovis | Fargo | North Dakota | 58103 | — |
| MeritCare Hospital | Fargo | North Dakota | 58122 | — |
| Trinity Health - Hospital | Minot | North Dakota | 58701 | — |
| University Hospital | Cincinnati | Ohio | 45219 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| Wright-Patterson Medical Center | Wright-Patterson AFB | Ohio | 45433 | — |
| Legacy Good Samaritan | Portland | Oregon | 97210 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | — |
| The Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | — |
| Memorial Hospital of RI | Pawtucket | Rhode Island | 02860 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Infectious Disease Consultations - Rapid City | Rapid City | South Dakota | 57701 | — |
| Avera Research Institute | Sioux Falls | South Dakota | 57105 | — |
| Vanderbilt University | Nashville | Tennessee | 37205 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8884 | — |
| The University of Texas Medical Branch | Galveston | Texas | 77555-0167 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center | San Antonio | Texas | 78229-3900 | — |
| Wilford Hall Medical Center | San Antonio | Texas | 78236 | — |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00068055, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2011 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00068055 live on ClinicalTrials.gov.