At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 47 enrolled
Drug / intervention
Kedrion IVIG 10%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 Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients
In Brief
A Phase 3 clinical trial evaluating Kedrion IVIG 10% for Primary Immunodeficiency Disease. Completed, enrolled 47 participants across 11 sites.
Detailed Summary
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedMay 2019
Primary CompletionDec 2020
TodayJul 2026
First PostedMay 23, 2019
Enrollment StartApr 30, 2019
Primary CompletionDec 21, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.1 years ago
Interventions
Kedrion IVIG 10%biological
Kedrion intravenous immunoglobulin (IVIg) 10%