At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 45 enrolled
Drug / intervention
Kedrion IVIG 10%biological
Likely dose
Kedrion IVIG 10% 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.
Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).
In Brief
A Phase 3 clinical trial evaluating Kedrion IVIG 10% for Primary Immunodeficiency and 3 related conditions. Completed, enrolled 45 participants across 15 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartNov 2012
Primary CompletionAug 2014
TodayJul 2026
First PostedApr 20, 2012
Enrollment StartNov 12, 2012
Primary CompletionAug 27, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.2 years ago
Interventions
Kedrion IVIG 10%biological
Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months