The purpose of the study is to acquire additional data on safety and tolerability of recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration. Following a discussion with the FDA at the end of July 2012, all participants still active in the study stopped treatment with rHuPH20 to assure safety of the participants participating in the study and went into a safety follow-up. During this safety follow-up period, participants underwent treatment with the licensed product IGI, 10% (Gammagard Liquid). The intravenous or subcutaneous administration route was at the discretion of the participant and the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Subcutaneous administration will be used in Study Epochs 1 and 2.
rHuPH20 will be administered subcutaneously (SC) immediately before each SC IGI, 10% infusion, through the same needle, at a rate of 1 to 2 mL/min.
University of California, Irvine
Irvine, California, United States
IMMUNOe International Research Centers
Thornton, Colorado, United States
Allergy Associates of the Palm Beaches, PA
North Palm Beach, Florida, United States
LSU Health Sciences Center & Children´s Hospital
New Orleans, Louisiana, United States
Midwest Immunology
Plymouth, Minnesota, United States
Midlands Pediatrics PC
Papillion, Nebraska, United States
Winthrop Allergy and Immunology
Mineola, New York, United States
Oklahoma Institute of Allergy & Asthma Clinical Research
Oklahoma City, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Allergy, Asthma & Immunology Clinic PA
Irving, Texas, United States
Number of Related Systemic Adverse Events (Excluding Infections)
Time frame: 7 months (per subject)
Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion
A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model.
Time frame: 7 months (per subject)
Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2
Time frame: 6 months (per subject)
Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks
Time frame: 6 months (per subject)
Number of Related Local Adverse Events (Excluding Infections)
Time frame: 7 months (per subject)
Rate of Related Local Adverse Events (Excluding Infections) Per Infusion
A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model.
Time frame: 7 months (per subject)
Number of All Related Adverse Events (Excluding Infections)
Time frame: 7 months (per subject)
Rate of All Adverse Events (Excluding Infections) Per Infusion
A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model.
Time frame: 7 months (per subject)
Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20
Time frame: 7 months (per subject)
Trough Levels of Immunoglobulin G (IgG)
IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed.
Time frame: 7 months (per subject)
Number of Infusions Per Month in Epoch 1 and Epoch 2
Non-parametric descriptive statistics (median, range) are provided.
Time frame: 7 months (per subject)
Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2
Non-parametric descriptive statistics (median, range) are provided.
Time frame: 7 months (per subject)
Duration of Infusion in Epoch 1 and Epoch 2
Non-parametric descriptive statistics (median, range) are provided.
Time frame: 7 months (per subject)
Maximum Infusion Rate in Epoch 1 and Epoch 2
Non-parametric descriptive statistics (median, range) are provided.
Time frame: 7 months (per subject)
Number of Weeks to Reach Final 3 or 4-week Dose Interval
Non-parametric descriptive statistics (median, range) are provided.
Time frame: 7 months (per subject)
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