IVIG - West Nile Encephalitis: Safety and Efficacy
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|ClinicalTrials.gov Identifier: NCT00068055|
Recruitment Status : Completed
First Posted : September 8, 2003
Last Update Posted : February 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|West Nile Virus||Drug: Omr-lgG-am Drug: Polygam® S/D Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
60 subjects to receive Omr-IgG-am.
Omr-IgG-am™ 5% is provided in 100 ml bottles (5.0 grams) as a sterile solution containing 5% protein, 10% maltose and water for injection. This product is licensed in Israel, but not in the US.
Active Comparator: 2
20 subjects to receive Polygam® S/D (IVIG).
Drug: Polygam® S/D
Polygam® S/D is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. When reconstituted (5%) with the supplied diluent (sterile water for injection, USP) Polygam® S/D contains approximately 50mg of protein per ml (approximately 90% is gamma globulin); 3mg/ml human albumin, 22.5 mg/ml glycine, 20 mg/ml glucose, 2mlg/ml polyethylene glycol (PEG), 1 mcg/ml tri-nbutyl phosphate, 1 mcg/ml octoxynol 9, and 100 mcg/ml polysorbate 80.
Placebo Comparator: 3
20 subjects to receive normal saline.
- Safety (including all causes of mortality) in the test IVIg (Omr-IgG-am™) group versus the 2 placebo groups, as defined by the total number of serious adverse events regardless of relatedness to study drug administration. [ Time Frame: Duration of study. ]
- Pharmacokinetics of specific anti-WNV antibodies as measured by ELISA and PRNT methods. [ Time Frame: Baseline (pre-dose) blood sample collected immediately prior to the beginning of the infusion. After the infusion, additional blood samples collected at 1 hr, 6 hr, 12 hr, 24 hr, 72 hr, and then at Day 5, Day 7, Day 14, Day 30, Day 60 and Day 90. ]
- Proportion of patients returning to pre-morbid baseline at 3 months, between treated and untreated groups of patients with WNV infection, as assessed by two scoring systems the Barthel Index and the MRS. [ Time Frame: At 3 months. ]
- Improvement as compared to subject's own worst (of any earlier) evaluation, for each subject as defined by the combined results of the 4 neurological functional tests. [ Time Frame: At 3 months. ]
- Mortality alone among confirmed WNV patients. [ Time Frame: At 3 months. ]
- Combined morbidity and mortality in treatment versus placebo groups for all (including those without WNV infection) subjects by intention to treat analysis. [ Time Frame: At 3 months. ]
- Combined primary endpoint of mortality and morbidity among confirmed WNV patients as assessed by four scoring systems: the Barthel Index, the MRS, the GOS and the 3MS, in the experimental treatment group versus the control group. [ Time Frame: At 3 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068055