The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered
1. IV infusion of IGIV, 10% to determine pharmacokinetics 2. Intervention as in Arm 1: Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered
First Allergy and Clinical Research Center
Centennial, Colorado, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States
Pediatrics Allergy/Immunology Association, PA
Dallas, Texas, United States
Ability to administer, after priming with recombinant human hyaluronidase, at least one half of a 4-week dose (minimum of 200 mg/kg) of IgG in a single infusion site, via the subcutaneous route, with no more than mild local adverse drug reactions.
Time frame: 72 hours
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