Thirty patients aged 2 to 17yo to be enrolled over five European countries
The first patient has been treated in Kedrion’s KIDCARES10 clinical trial.
KIDCARES10 stands for KIg10 in peDiatric subjects: effiCacy, sAfety and phaRmacokinEticS of a 10% IG. It is a phase III, open-label, prospective, multi-center study that will assess efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years who are affected by Primary Immunodeficiency Disease (PI).
“The number of patients who require treatment for primary immune deficiency continues to grow as this rare and serious medical condition becomes more and more well recognized and diagnosed by healthcare professionals,” said Prof. Claudio Pignata, Professore Ordinario di Pediatria and treating physician at the Dipartimento di Scienze Mediche Traslazionali – Università Federico II in Napoli, Italy, the KIDCARES10 clinical site where the first patient has been treated. “Data produced by the KIDCARES10 study will be extremely important in advancing an even deeper understanding of primary immune deficiency in children. We are certainly pleased and proud to be participating in this important trial.”
Dr. Emilia Cirillo is the University researcher of the team led by Prof. Claudio Pignata.
“Kedrion Biopharma remains committed to making meaningful contributions to advancing the world’s understanding of the science of certain rare and serious diseases,” said Novinyo Serge Amega, M.D., head of U.S. Medical Affairs at Kedrion Biopharma. “The KIDCARES10 study is a clear illustration of that commitment. It is particularly gratifying to be working toward helping children who are diagnosed with primary immune deficiency.”
KIDCARES10 will enroll 30 patients in 18 sites across five countries (Italy, Portugal, Hungary, Slovak Republic and Russia). Its results will be submitted to the U.S. Food and Drug Administration.
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