At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
Immune Globulin Intravenous (Human), 10%drug
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.
Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases
In Brief
A Phase 3 clinical trial evaluating Immune Globulin Intravenous (Human), 10% for Primary Immunodeficiency Diseases (PID). Completed, enrolled 49 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency Diseases (PID)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedOct 2007
Primary CompletionJul 2009
Study CompletionSep 2009
TodayJul 2026
First PostedOct 19, 2007
Enrollment StartOct 3, 2007
Primary CompletionJul 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.7 years ago
Interventions
Immune Globulin Intravenous (Human), 10%drug
Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3