| Autor: |
Pasca, Samantha, PierGiorgio, Cojutti, Pea, Federico |
| Zdroj: |
Journal of Thrombosis & Thrombolysis; Nov2022, Vol. 54 Issue 4, p593-596, 4p |
| Abstrakt: |
Background: FXIII deficiency is a very rare coagulation disorder that can affect equally males and females with an estimated incidence of 1 in 2 million persons worldwide. Due to this rarity, there are only few clinical and pharmacokinetic (PK) data deriving from the real-world. Aim: The aim of this report is to compare head-to-head the pharmacokinetic data of catridecacog derived from the MENTORTM2 trial with our real-world (RW) study. Methods: The PK-profiles of all patients with FXIII deficiency treated with catridecacog at eleven Italian Hemophilia Centers were compared with PK data obtained by Kerlin et al. in the MENTORTM2. Results: Overall 18 real-world PK were compared with 23 PK derived from the pivotal study. In the RW 55.6% of patients were females, 26.2% in the MENTORTM2 (p < 0.05). The mean dosage of drug used for the PK assessment was 35 IU/kg in the MENTORTM2, and 33.9 IU/kg in the RW study. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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