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) identifier identifier identifier

  • 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.