The last patient has recently been treated in the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% 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).
“The CARES10 trial spans a robust set of endpoints including clinical, laboratory, and health-related quality of life measures of the patients’ experience with a 10 percent IVIG, an essential treatment for a rare and serious condition, primary immunodeficiency,” said Novinyo Serge Amega, M.D., head of U.S. Medical Affairs at Kedrion Biopharma.
CARES10 enrolled 47 patients in 11 sites across U.S.; the study’s results will form the basis of a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).
“Now that all patients have been treated, we look forward to the analysis phase of the study,” Dr. Amega concluded.