Primary Immune Deficiency Clinical Trial
Official title:
Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous
injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune
deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL)
evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to
determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK
outcomes on weekly and biweekly IgPro20 therapy.
Patients who have received and/or are currently receiving immunoglobulin G (IgG) in
intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet
inclusion/exclusion criteria.
The study consists of two parts. In Part 1 of the study enrolled subjects will receive
IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24
weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly
treatment with IgPro20 for 52 weeks, for both groups.
Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a
PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.
n/a
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