Non-Compartment and compartmental pharmacokinetics, efficacy, and safety of Kedrion FIX concentrate

Castaman, G.; Borchiellini, A.; Santagostino, E.; Radossi, P.; Aksu, S.; Yilmaz, M.; Serban, M.; Uscatescu, V; Truica, C.; Fasulo, M.; Mancuso, M.; Paladino, E.; Valpreda, A.; Guarnieri, C.; Macchia, R.; Scarpellini, M.; Mathew, P.; Morfini, M.

doi:10.1016/j.ejps.2020.105485

Non-Compartment and compartmental pharmacokinetics, efficacy, and safety of Kedrion FIX concentrate

Castaman G., Borchiellini A., Santagostino E., Radossi P., Aksu S., Yilmaz M., ...More

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol.153, 2020 (Journal Indexed in SCI)

Publication Type: Article / Article
Volume: 153
Publication Date: 2020
Doi Number: 10.1016/j.ejps.2020.105485
Title of Journal : EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Abstract

Background: An open-label phase II, multicenter clinical trial was conducted at 11 Haemophilia Centres in Italy, Romania, and Turkey, to evaluate the pharmacokinetics (PK), efficacy, and safety of high purity, plasma-derived, double virus inactivated and double nano-filtered factor IX (pd-FIX) concentrate (Kedrion FIX), EudraCT Number: 2005-006186-14.