Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
Status:
Completed
Trial end date:
2018-12-14
Target enrollment:
Participant gender:
Summary
This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate
safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary
immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric
subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of
≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three
cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions),
volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly
infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push
Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30
mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each
cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort),
repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort).
After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the
next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose
will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per
week range); only the respective infusion parameter under evaluation will change.