At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 enrolled
Drug / intervention
Immune Globulin Intravenous (Human) Omr-IgG-am IGIVdrug
Likely dose
Immune Globulin Intravenous (Human) Omr-IgG-am IGIV 900 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study of Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in Subjects With Primary Immune Deficiency Diseases
In Brief
A Phase 3 clinical trial evaluating Immune Globulin Intravenous (Human) Omr-IgG-am IGIV for Immunologic Deficiency Syndromes. Completed, enrolled 57 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) \[IGIV\], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunologic Deficiency Syndromes
CountriesCanada, United States
CollaboratorsOMRIX Biopharmaceuticals
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedMay 2007
Primary CompletionMay 2009
Study CompletionAug 2009
TodayJul 2026
First PostedMay 2, 2007
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.2 years ago
Interventions
Immune Globulin Intravenous (Human) Omr-IgG-am IGIVdrug
IGIV infusions of 300-900 mg/kg every 3 or 4 weeks