At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
Immune Globulin Intravenous (Human), 10% Solution +1 morebiological
Likely dose
Not stated in 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 Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)
In Brief
A Phase 3 clinical trial evaluating Immune Globulin Intravenous (Human), 10% Solution and Immune Globulin Subcutaneous (Human), 20% Solution for Primary Immunodeficiency Diseases (PID). Completed, enrolled 86 participants across 18 sites in 2 countries.
Detailed Summary
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency Diseases (PID)
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartJan 2013
Primary CompletionMar 2015
TodayJul 2026
First PostedOct 11, 2010
Enrollment StartJan 28, 2013
Primary CompletionMar 13, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.7 years ago
Interventions
Immune Globulin Intravenous (Human), 10% Solutionbiological
Intravenous infusion with IGIV, 10%
Immune Globulin Subcutaneous (Human), 20% Solutiondrug
Subcutaneous infusion with IGSC, 20%