The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).
People with primary immunodeficiency diseases (PID) have a defective immune system and experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies make up the largest group of PIDs. The standard care for patients with PID is replacement immunoglobulin (a class of antibodies) solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been shown to increase the time free from serious infection. Kedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10% will be given by IV infusion to all study participants. The data collected will help determine whether Kedrion IVIG 10% is suitable for treating PID subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States
Incidence of Acute, Serious Bacterial Infections in the Total ITT Population.
The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis, meeting EMA and FDA criteria.
Time frame: 13 months
Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population.
Time frame: 13 months
Days Out of Work/School/Daycare Due to Infection in the Total ITT Population.
Time frame: 13 months
Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population.
Time frame: 13 months
Days on Therapeutic Antibiotics in the Total ITT Population.
Time frame: 13 months
Days of Unscheduled Visits to Physicians in the Total ITT Population.
Time frame: 13 months
Number of Hospitalizations Due to Infection in ITT Population.
Time frame: 13 months
Days of Hospitalization Due to Infection in the Total ITT Population.
Time frame: 13 months
Yearly Hospitalization Rate Due to Infection in the Total ITT Population.
Time frame: 13 months
Yearly Hospitalization Duration Due to Infection in the Total ITT Population.
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Family Allergy & Asthma Center, PC
Atlanta, Georgia, United States
Rush University
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Midwest Immunology Clinic
Plymouth, Minnesota, United States
AAIR Research Center
Rochester, New York, United States
Optimed Research, LTD
Columbus, Ohio, United States
Dallas Allergy Immunology Research
Dallas, Texas, United States
AARA Research Center
Dallas, Texas, United States
...and 5 more locations
Time frame: 13 months
Distribution of All-cause Hospitalizations in the Total ITT Population.
Time frame: 13 months
Duration of All-cause Hospitalizations
Time frame: 13 months
Distribution of Fever Episodes in the Total ITT Population.
Time frame: 13 months
Duration of Fever Episodes
Time frame: 13 months
IgG Trough Levels at Steady State in the Total ITT Population.
Time frame: 13 months