Thirty patients aged 2 to 17 years old to be enrolled over five European countries<\/p>\n\n\n\n\n\n\n\n
On March 31, the first patient has been enrolled in Kedrion\u2019s KIDCARES10 clinical study at the Azienda Universitaria Federico II \u2013 Unit\u00e0 operativa di Immunologia Pediatrica \u2013 Reparto di Immunologia Pediatrica (Principal Investigator: Prof. Claudio Pignata) in Naples, Italy.<\/p>\n\n\n\n
KIDCARES10 stands for KI<\/strong>g10 in peD<\/strong>iatric subjects: effiCa<\/strong>cy, sA<\/strong>fety and phaR<\/strong>macokinEt<\/strong>icS <\/strong>of a 10<\/strong>% 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 old who are affected by primary immunodeficiency disease (PI) over a period of 13 months.<\/p>\n\n\n\n \u201cMany pediatricians who see patients diagnosed with Primary Immunodeficiency share a common goal, which is to gain an even broader understanding of the efficacy and safety of administering Immunoglobulin treatment to children affected by this condition,\u201d said Leading Investigator, Prof. Chiara Azzari, Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer Dipartimento Assistenza Integrata (DAI) di Pediatria Internistica. \u201cFor this reason, today\u2019s news about the first patient being enrolled in KIDCARES10 is certainly welcome and exciting.\u201d<\/p>\n\n\n\n KIDCARES10 is set to enroll 30 patients over 18 sites in 5 countries (Italy, Portugal, Hungary, Slovakia and Russia). Its results will be submitted to the U.S. Food and Drug Administration.<\/p>\n\n\n\n Primary efficacy endpoint of KIDCARES10 is incidence rate of acute serious bacterial infections from day 1 to week 51\/52, while primary safety endpoint is safety in the overall study population from day 1 to week 51\/52. Secondary endpoints of KIDCARES10 include clinical, laboratory, pharmacokinetic, and health-related quality of life (HRQoL) measures.<\/p>\n\n\n\n \u201cThe KIDCARES10 Study is another important clinical research endeavor for Kedrion Biopharma,\u201d said Novinyo Serge Amega, M.D., head of U.S. Medical Affairs at Kedrion Biopharma. \u201cFocusing as it does on pediatric patients who have been diagnosed with Primary Immunodeficiency disease, this trial could certainly yield valuable insights into how best to treat children who have been diagnosed with this rare and serious disorder.\u201d<\/p>\n","protected":false},"featured_media":0,"template":"","categories_news":[],"class_list":["post-5671","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"\n