Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068055
Status:
COMPLETED
Last Update Posted:
2011-02-07
First Post:
2003-09-04
Brief Title:
IVIG - West Nile Encephalitis Safety and Efficacy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III 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 andor Myelitis
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 SD 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
Detailed Description:
The purpose of this study is to assess whether Omr-IgG-am 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 III study will enroll hospitalized adults with a presumptive diagnosis of West Nile encephalitis andor 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-IgGam Polygam SD IVIG containing minimal anti-WNV antibodies or normal saline in a ratio of 311 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 05 gramskg of Omr-IgG-am or Polygam SD 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 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 versus those receiving either placebo and between the two placebo groups Other secondary endpoints include the proportion of patients in each group returning to pre-morbid baseline and each subjects improvement at 3 months as compared to that subjects worst of any previous evaluation Natural history endpoints will also be assessed They will include the duration of intensive care unit and hospital stay development and persistence of WNV-specific IgG and IgM antibodies combined functional score and mortality at 3 months between the group with encephalitis andor myelitis at baseline versus the group with a positive WNV test only outcomes in patients treated late in coma and correlation of outcome with time-to-treatment following symptom onset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASG 210 | None | None | None |