Since 2018 Kedrion has had exclusive distribution rights in the US for KEDRAB®, a Human Rabies Immune Globulin developed in partnership with Kamada Ltd.New agreement becomes effective in January.
/PRNewswire/ Kedrion Biopharma, an international biopharmaceutical company specialized in the manufacture and distribution of plasma-derived therapeutic.
First Patient Enrolled in KIDCARES10, Kedrion Biopharma Pediatric Primary Immunodeficiency Study
- Objectives of KIDCARES10 Study (KIg10 in peDiatric subjects: effiCacy, sAfety and phaRmacokinEticS of a 10% IG) a phase III, open-label, prospective, multi-center study are to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency disease (PI)
- Primary efficacy endpoint of KIDCARES10 is incidence rate of acute serious bacterial infections from day 1 to week 51/52
- Primary safety endpoint of KIDCARES10 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