This is a Phase IV, multicenter, open-label study of Asceniv™ administered as an intravenous infusion of Asceniv™ (IGIV) 300-800 mg/kg every 21 or 28 days in approximately 12 pediatric subjects with Primary Immunodeficiency Diseases (PIDD). The study will be conducted at 5-7 centers in the United States, with subjects receiving six (28 day cycle) or seven (21 day cycle) doses of Asceniv™ during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Each subject will receive an intravenous infusion of Asceniv™ on Study Day 1 (required to be within 28 days of screening) and every 21 or 28 days thereafter according to their current interval of IGIV treatment. Subjects will receive Asceniv™ at the same dose or higher dose if medically appropriate (300-800 mg/kg), every 21 or 28 days for five months (seven or six doses respectively).
Immunoe Research Centers
Centennial, Colorado, United States
NOT_YET_RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
NOT_YET_RECRUITINGCmax
Pharmacokinetic measure at 6th or 7th infusion
Time frame: At prior to, end of infusion, and 60 minutes, 2 hours, 24 hours, 48 hours, 4 days, 7 days, 14 days, and either 21 or 28 days dependent upon infusion schedule
Tmax
Pharmacokinetic measure at 6th or 7th infusion
Time frame: At prior to, end of infusion, and 60 minutes, 2 hours, 24 hours, 48 hours, 4 days, 7 days, 14 days, and either 21 or 28 days dependent upon infusion schedule
AUC(0-ʈ)
Pharmacokinetic measure at 6th or 7th infusion
Time frame: At prior to, end of infusion, and 60 minutes, 2 hours, 24 hours, 48 hours, 4 days, 7 days, 14 days, and either 21 or 28 days dependent upon infusion schedule
AUC(0-∞)
Pharmacokinetic measure at 6th or 7th infusion
Time frame: At prior to, end of infusion, and 60 minutes, 2 hours, 24 hours, 48 hours, 4 days, 7 days, 14 days, and either 21 or 28 days dependent upon infusion schedule
Terminal phase elimination half-life (ʈ½)
Pharmacokinetic measure at 6th or 7th infusion
Time frame: At prior to, end of infusion, and 60 minutes, 2 hours, 24 hours, 48 hours, 4 days, 7 days, 14 days, and either 21 or 28 days dependent upon infusion schedule
Terminal phase elimination rate (λZ)
Pharmacokinetic measure at 6th or 7th infusion
Time frame: At prior to, end of infusion, and 60 minutes, 2 hours, 24 hours, 48 hours, 4 days, 7 days, 14 days, and either 21 or 28 days dependent upon infusion schedule
Total IgG Trough
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Levels taken before each infusion
Time frame: At each visit through study completion, up to approximately 7 months
IgG Subclasses
Levels of subclasses 1-4 before infusion
Time frame: Prior to first and last infusions
Antibodies
Levels of specific antibodies (anti-pneumococcal capsular polysaccharide, anti-haemophilus influenzae b, and anti-RSV neutralizing antibody)
Time frame: Prior to first and last infusions
Infections
Number of infections of any kind, serious and non-serious
Time frame: Up to approximately 7 months
Serious Bacterial Infections
Incidence of Serious Bacterial Infections
Time frame: Up to approximately 7 months
Other Infections
Incidence of infections other than Serious Bacterial Infections
Time frame: Up to approximately 7 months
Hospitalizations
Number of hospitalizations due to infections
Time frame: Up to approximately 7 months