Primary Immunodeficiency Clinical Trial
Official title:
A Multi-Center, Open-Label, Single-Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency
Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) who complete the entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC 20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20% weekly doses). A total of 52 doses of IGSC 20% will be administered with a final follow-up visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained on self-administration of IGSC 20% by the clinical site personnel.
This is a prospective, multi-center, open-label, single-arm, efficacy, PK, safety and
tolerability study of IGSC 20% in subjects with PI. Approximately 60 subjects will be
enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated
with subcutaneously administered IGSC 20% who complete the entire study.
This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC 20% Treatment
Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20% weekly
doses).
Previous Regimen Phase: Subjects will be infused with their current ongoing ("previous
regimen") intravenous immune globulin/subcutaneous immune globulin (IVIG/SCIG) regimen
(pIV/pSC) in the clinic to obtain 2 trough immunoglobulin G (IgG) levels (obtained prior to
each pIV/pSC infusion) on each subject's "previous regimen".
20% IGSC Treatment Stage 1: The first dose of IGSC 20% will be administered at the clinical
site immediately after Baseline assessments are complete (SC#1). All subjects will receive 13
IGSC 20% infusions at weekly intervals. IgG trough blood levels will be measured at all
(except SC#3) study visits All other doses of IGSC 20% may be infused at home (once properly
trained) or in the clinic. The Treatment Stage 1 dose will continue into IGSC 20% Treatment
Stage 2.
IGSC 20% Treatment Stage 2: The IGSC 20% dose (mg/kg) will remain constant with no dose
adjustment permitted in this phase, unless it is absolutely medically necessary. While all
subjects will have a SC#17 clinic visit and standard assessments, serial pharmacokinetics
(PK) sampling will only be performed in a subset of adult subjects:
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