At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 33 enrolled
Drug / intervention
IGSC 20%biological
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 Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency
In Brief
A Phase 4 clinical trial evaluating IGSC 20% for Primary Immunodeficiency. Completed, enrolled 33 participants across 12 sites.
Detailed Summary
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionJul 2022
Study CompletionJul 2022
TodayJul 2026
First PostedSep 28, 2020
Enrollment StartNov 24, 2020
Primary CompletionJul 18, 2022
Study CompletionJul 25, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.8 years ago
Interventions
IGSC 20%biological
SC infusion pump.