At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 75 enrolled
Drug / intervention
octanorm 16.5%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.
Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases
In Brief
A Phase 3 clinical trial evaluating octanorm 16.5% for Primary Immune Deficiency Disorder. Completed, enrolled 75 participants across 24 sites in 7 countries.
Detailed Summary
This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Deficiency Disorder
CountriesCanada, Czechia, Hungary, Poland, Russia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartMar 2014
Primary CompletionJun 2020
TodayJul 2026
First PostedJun 27, 2013
Enrollment StartMar 1, 2014
Primary CompletionJun 9, 2020
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 13.0 years ago
Interventions
octanorm 16.5%biological
octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.