Kedrion Biopharma, an international specialist in the manufacture and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, has commenced the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) clinical study, it was reported yesterday.

CARES10 is a United States/Canada-based open-label, prospective, multi-centre phase three clinical study to evaluate efficacy, safety and pharmacokinetics of a 10% intravenous immunoglobulin in the treatment of adult patients with primary immunodeficiency diseases (PI).

It is also likely to enrol a limited number of paediatric patients in order to gather preliminary data in that population. To date, 20 patients are enrolled in CARES10. Enrolment will continue until January 2020, with the goal of reaching a total of around 50 patients.

The study is scheduled to be completed by mid-2021.