IVIG - West Nile Encephalitis: Safety and Efficacy

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: West Nile Virus

In brief

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.

Key facts

Study ID

NCT00068055

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

62

Starts

2003-09-01

Expected to finish

2006-12-01

Last updated by the study team

2011-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to participate in this clinical trial, all subjects (or legal representative) must provide written informed consent. Only patients meeting entry criteria will be enrolled. Eligible subjects must fall into one of two categories:
• A. Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below:
• New neurologic abnormality:
• Asymmetric extremity weakness without sensory abnormality; or
• Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days AND
• CSF examination within the previous 96 hours showing:
• Absence of organism on gram or fungal stain
• White blood cell count greater than or equal to 4 per cubic mm corrected for significant red blood cell contamination.
• Ratio of CSF: plasma glucose of greater than or equal to 40% (CSF glucose / plasma glucose greater than or equal to 0.4) Serum and CSF glucose levels should be obtained within 8 hours of each other for this calculation.
• OR
• B. Hospitalized patients, without encephalitis and/or myelitis as defined below, who meet the following criteria:
• A positive IgM serology or PCR test for WNV in blood or cerebrospinal fluid, AND
• Clinical illness compatible with WNV infection as described by occurrence of greater than or equal to 3 of the following findings during the preceding less than or equal to 10 days:
• Diarrhea
• Headache
• Fever > 38º C
• Nausea and/or vomiting
• Myalgias and/or arthralgias
• Nuchal rigidity
• Macular or papular rash
• New neurological abnormality AND
• A risk factor for the development of WNV neurologic disease as defined by:
• Age greater than or equal to 40 years, or
• Age greater than or equal to 18 years plus immunosuppression, as defined by any of the following:
• Hematologic malignancy; previous diagnosis of diabetes mellitus; chemotherapy within previous 4 weeks; stem cell transplant recipient or solid organ transplant recipient; taking immunosuppressive medications, including prednisone greater than or equal to 7.5 mg/day within the previous 4 weeks; history of human immunodeficiency virus (HIV) infection, congenital immunodeficiency syndrome (including common variable immunodeficiency)

You may not qualify if…

• Unable to obtain valid informed consent History of intolerance (including anaphylaxis) to IVIg or related compounds Known history of IgA deficiency Known history of hypersensitivity to maltose
• History of (or at time of study entry) hyperviscosity syndrome, such as but not limited to:
• Waldenstrom's macroglobulinemia
• Multiple myeloma
• Total white blood cell count > 80,000/cubic mm
• Hematocrit > 55%
• Platelet count > 700,000/cubic mm Meets criteria of Class III or IV of the New York Heart Association Classification for congestive heart failure patients Serum creatinine > 2.5 mg/dL or requires dialysis Alternate explanation (as determined by the investigator) for clinical findings (such as structural brain lesion, cerebrovascular accident, or other infectious disease, including confirmed infections with other flaviviruses) Pregnant or breastfeeding (negative serum or urine pregnancy test within previous 72 hours if woman is not postmenopausal or has not been surgically sterilized) Investigator's opinion that patient would be unable to adhere to protocol requirements Receipt of ribavirin, interferon alpha, intravenous immunoglobulin, or any investigational drug for treatment of WNV or hepatitis within 15 days prior to study entry

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Enloe Medical Center — Chico, California, United States
• Seton Medical Center — Daly City, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• Kaiser Permanente South Bay Medical Center — Harbor City, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California Irvine — Orange, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Santa Rosa Kaiser Medical — Santa Rosa, California, United States
• Exempla St. Joseph Hospital — Denver, Colorado, United States
• University of Colorado — Denver, Colorado, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Idaho Falls Infectious Diseases, PLLC — Idaho Falls, Idaho, United States
• Loyola University — Maywood, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Via Christi Regional Medical Center — Wichita, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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