At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 42 enrolled
Drug / intervention
HYQVIA +2 morebiological
Likely dose
KIOVIG 100 mgfrom 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.
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases
In Brief
A Phase 4 clinical trial evaluating HYQVIA, KIOVIG, and 1 other intervention for Primary Immunodeficiency Diseases (PID). Completed, enrolled 42 participants across 20 sites in 8 countries.
Detailed Summary
The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to \<18 years) patients with Primary Immunodeficiency Diseases (PIDD)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency Diseases (PID)
CountriesCzechia, Denmark, France, Greece, Hungary, Slovakia, Sweden, United Kingdom
CollaboratorsBaxalta Innovations GmbH, now part of Shire
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionJan 2021
TodayJul 2026
First PostedApr 17, 2017
Enrollment StartMay 30, 2017
Primary CompletionJan 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.2 years ago
Interventions
HYQVIAbiological
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)
KIOVIGbiological
100 mg/ml solution for Immune Globulin Intravenous Infusion
Cuvitrubiological
200 mg/ml solution for Immune Globulin Subcutaneous Injection