At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
GC5107biological
Likely dose
GC5107 20gfrom 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.
An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
In Brief
A Phase 3 clinical trial evaluating GC5107 for Immunologic Deficiency Syndromes. Completed, enrolled 49 participants across 20 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunologic Deficiency Syndromes
CountriesCanada, United States
CollaboratorsParexel, Atlantic Research Group
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartOct 2016
Primary CompletionJul 2019
TodayJul 2026
First PostedMay 26, 2016
Enrollment StartOct 1, 2016
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.1 years ago
Interventions
GC5107biological
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)