Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
Biological: Kedrion IVIG 10%
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).|
- Incidence of acute, serious bacterial infections [ Time Frame: 13 months ] [ Designated as safety issue: No ]The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, visceral abscess.
- Incidence of infections other than acute, serious bacterial infections [ Time Frame: 13 months ] [ Designated as safety issue: No ]The incidence of infections other than acute serious bacterial infections.
- Evidence of change in daily activities due to infections [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- The number of days missed from work, school, kindergarten, day care, or days unable to perform normal daily activities due to infections.
- Days of unscheduled physician visits and hospitalizations due to infection.
- Days of therapeutic antibiotics.
- IgG serum levels [ Time Frame: every month up to 13 months ] [ Designated as safety issue: No ]
- IgG trough levels
- Trough serum total IgG levels before each infusion of Kedrion IVIG 10% in all subjects and the interval between infusions will be recorded.
- Incidence of adverse events [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
- Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product.
- The proportion of adverse events considered by the investigator to be product related.
- Incidence of decreased infusion rate due to adverse events [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]The proportion and number of IVIG infusions for which the infusion rate was decreased due to adverse events.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Kedrion IVIG 10%
Kedrion IVIG 10% treatment.
Biological: Kedrion IVIG 10%
Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Duration - 12 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581593
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|United States, Florida|
|Allergy Associates of the Palm Beaches|
|North Palm Beach, Florida, United States, 33408|
|United States, Georgia|
|Family Allergy & Asthma Center, PC|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|United States, Iowa|
|University of Iowa Hospital and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Minnesota|
|Midwest Immunology Clinic|
|Plymouth, Minnesota, United States, 55446|
|United States, New York|
|AAIR Research Center|
|Rochester, New York, United States, 14618|
|United States, Ohio|
|Optimed Research, LTD|
|Columbus, Ohio, United States, 43235|
|United States, Texas|
|Dallas Allergy Immunology Research|
|Dallas, Texas, United States, 75230|
|AARA Research Center|
|Dallas, Texas, United States, 75231|
|United States, Virginia|
|Virginia Commonwealth University Health Systems|
|Richmond, Virginia, United States, 23298|
|United States, Washington|
|Marycliff Allergy Specialists|
|Spokane, Washington, United States, 99204|
|Gordon Sussman Clinical Research Inc.|
|Toronto, Ontario, Canada, M4V1R2|
|Pediatric & Adult Allergy & Clinical Immunology|
|Toronto, Ontario, Canada, M5G1E2|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Study Director:||Mirella Calcinai, MD||Kedrion SpA|