Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069316
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-09-22
Brief Title:
Omr-IgG-amTrademark for Treating Patients With or at High Risk for West Nile Virus Disease
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
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 VirusWNV
Status:
COMPLETED
Status Verified Date:
2011-02-18
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:
Investigators will assess whether Omr-IgG-amTrademark 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-IgG-amTrademark PolygamRegistered Trademark 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-amTrademark or PolygamRegistered Trademark 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-amTrademark 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-amTrademark 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 ICU 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
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-IgG-amTrademark PolygamRegistered Trademark 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-amTrademark or PolygamRegistered Trademark 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-amTrademark 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-amTrademark 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 ICU 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
Detailed Description:
Investigators will assess whether Omr-IgG-amTrademark 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-IgG-amTrademark PolygamRegistered Trademark 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-amTrademark or PolygamRegistered Trademark 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-amTrademark 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-amTrademark 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 ICU 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
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-IgG-amTrademark PolygamRegistered Trademark 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-amTrademark or PolygamRegistered Trademark 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-amTrademark 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-amTrademark 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 ICU 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 |
|---|---|---|---|
| 03-CC-0306 | None | None | None |