- * Male or female on stable dose of IgPro20 (Hizentra) therapy.
- * Women of childbearing potential must be using and agree to continue using medically approved contraception (which must be discussed with the study doctor) and must have a negative pregnancy test at screening.
- * Subjects with PID, eg, with a diagnosis of common variable immunodeficiency or X-linked agammaglobulinemia, as defined by the Pan American Group for Immune Deficiency and the European Society of Immune Deficiencies.
- * With infusion parameters as specified below:
- Pump-Assisted Flow Rate Cohort subjects only
- * Experience with pump-assisted infusions of IgPro20 at the tolerated flow rate of 25 mL/h per injection site for at least 1 month prior to Day 1.
- Pump-Assisted Volume Cohort subjects only
- * Total weekly IgPro20 dose of ≥ 50 mL (≥ 10 g).
- * Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25 mL/injection site for at least 1 month prior to Day 1.
- Manual Push Flow Rate Cohort subjects only
- * Experience with frequent (2-7 times per week) infusions of IgPro20 at the tolerated flow rate of approximately 0.5 mL/min (equivalent of 25-30 mL/h) per injection site for at least 1 month prior to Day 1. The dose (volume) per injection site should not exceed 25 mL.
Primary Immunodeficiency
Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
NCT03033745 | PHASE 4 | INTERVENTIONAL
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), re
Trial Information
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Clinical Research Center of Alabama
Birmingham,Alabama,United States,35209
Research Solutions of Arizona
Litchfield Park,Arizona,United States,85340
University of Southern Florida
Saint Petersburg,Florida,United States,33701
Georgia Pollens Clinical Research Centers
Albany,Georgia,United States,31707
Long Island Jewish Medical Center
Great Neck,New York,United States,11021
Icahn Medical Institute
New York,New York,United States,10029
Center for Clinical Research Rochester General Hospital
Rochester,New York,United States,14607
Levine Children's Hospital
Charlotte,North Carolina,United States,28203
Duke University School of Medicine
Durham,North Carolina,United States,27705
Medical College of Wisconsin
Milwaukee,Wisconsin,United States,53226
The Ottawa Hospital
Ottawa,Ontario,Canada,K1H8L6
McGill University
Montréal,Quebec,Canada,H4A3J1
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