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:
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.
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.
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.

NCT03033745_inc_T1
Person
Male
NCT03033745_inc_T2
Person
female
NCT03033745_inc_T3
Drug
IgPro20
NCT03033745_inc_T4
Drug
Hizentra
NCT03033745_inc_T5
Qualifier
stable dose
NCT03033745_inc_T7
Condition
PID
NCT03033745_inc_T8
Condition
common variable immunodeficiency
NCT03033745_inc_T9
Condition
X-linked agammaglobulinemia
NCT03033745_inc_T10
Measurement
Pan American Group for Immune Deficiency
NCT03033745_inc_T11
Measurement
European Society of Immune Deficiencies
NCT03033745_inc_T13
Scope
Pan American Group for Immune Deficiency and the European Society of Immune Deficiencies
NCT03033745_inc_T14
Scope
common variable immunodeficiency or X-linked agammaglobulinemia
NCT03033745_inc_T15
Qualifier
pump-assisted infusions
NCT03033745_inc_T16
Drug
IgPro20
NCT03033745_inc_T17
Multiplier
flow rate of 25 mL/h per injection site
NCT03033745_inc_T18
Qualifier
tolerated
NCT03033745_inc_T19
Temporal
for at least 1 month prior to Day 1
NCT03033745_inc_T20
Reference_point
Day 1
NCT03033745_inc_T21
Qualifier
weekly
NCT03033745_inc_T22
Drug
IgPro20
NCT03033745_inc_T23
Multiplier
= 50 mL
NCT03033745_inc_T24
Multiplier
= 10 g
NCT03033745_inc_T25
Qualifier
pump-assisted infusions
NCT03033745_inc_T26
Drug
IgPro20
NCT03033745_inc_T27
Multiplier
volumes of 25 mL/injection site
NCT03033745_inc_T28
Qualifier
tolerated
NCT03033745_inc_T29
Temporal
for at least 1 month prior to Day 1
NCT03033745_inc_T30
Reference_point
Day 1
NCT03033745_inc_T31
Qualifier
frequent
NCT03033745_inc_T32
Drug
IgPro20
NCT03033745_inc_T33
Multiplier
ection site for at te of approximately 0.5 mL/min (equiv
NCT03033745_inc_T34
Multiplier
25-30 mL/h
NCT03033745_inc_T35
Temporal
for at least 1 month prior to Day 1
NCT03033745_inc_T36
Reference_point
Day 1
NCT03033745_inc_T37
Multiplier
2-7 times per week
NCT03033745_inc_T38
Negation
not
NCT03033745_inc_T39
Multiplier
exceed 25 mL.