Study to assess efficacy, safety and pharmacokinetics of a 10 percent Immunoglobulin in PI patients.<\/p>\n\n\n\n\n\n\n\n
The last patient has recently been treated in the CARES10 (C<\/strong>linical A<\/strong>ssessment of phaR<\/strong>macokinetics, E<\/strong>fficacy, S<\/strong>afety of a 10<\/strong>% Ig) trial. CARES10 is a phase III, open-label, prospective, multi-center study that assesses efficacy, safety, and pharmacokinetics of a 10 percent intravenous Immunoglobulin (IVIG) in individuals diagnosed with Primary Immunodeficiency disease (PI).<\/p>\n\n\n\n \u201cThe CARES10 trial spans a robust set of endpoints including clinical, laboratory, and health-related quality of life measures of the patients\u2019 experience with a 10 percent IVIG, an essential treatment for a rare and serious condition, primary immunodeficiency,\u201d said Novinyo Serge Amega, M.D., head of U.S. Medical Affairs at Kedrion Biopharma.<\/p>\n\n\n\n CARES10 enrolled 47 patients in 11 sites across U.S.; the study\u2019s results will form the basis of a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).<\/p>\n\n\n\n \u201cNow that all patients have been treated, we look forward to the analysis phase of the study,\u201d Dr. Amega concluded.<\/p>\n","protected":false},"featured_media":0,"template":"","categories_news":[46],"class_list":["post-5104","news","type-news","status-publish","hentry","categories_news-plasma-biotherapies-en-us"],"acf":[],"yoast_head":"\n