Pharmacokinetic characteristics of the triple inactivated plasma-derived Kedrion FIX concentrate: data from the KB037 clinical trial
| Autor: | Manuela Scarpellini, Chiara Guarnieri, Roberta Macchia, Massimo Morfini, Prasad Mathew |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Plasma-derived FIX concentrate
Non-compartment Analysis Pharmacology lcsh:Computer applications to medicine. Medical informatics Decay curve 03 medical and health sciences One and Two Compartment Model 0302 clinical medicine Pharmacokinetics Haemophilia B medicine lcsh:Science (General) 030304 developmental biology Mathematics 0303 health sciences Multidisciplinary Plasma derived PK Parameters Medicine and Dentistry medicine.disease Clinical trial lcsh:R858-859.7 030217 neurology & neurosurgery Efficacy Study lcsh:Q1-390 |
| Zdroj: | Data in Brief, Vol 32, Iss, Pp 106164-(2020) Data in Brief |
| ISSN: | 2352-3409 |
| Popis: | The pharmacokinetics data of phase I/II clinical trials (EudraCT Number: 2005-006186-14) of the new, triple inactivated plasma-derived Kedrion FIX concentrate was designed according to the recommendations of SSC-ISTH [ 1 , 2 ]: 11 post-infusion FIX/time points samples during the first 72 h. The PK data were also analysed by a modified, less dense, 9 FIX/time points, sample design. The outcomes of the safety and efficacy study and the pharmacokinetics' results have been previously and partially described [ 3 , 4 ]. The single-dose PK at enrolment (PK I) and the end of the trial (PK II) were analyzed by WinNonlin 7.0 (Pharsight) and according to three different methods: Non-Compartment Analysis (NCA), One Compartment Method (OCM), and Two-Compartment Method (TCM). The outcomes of PK parameters by TCM show that a higher number of FIX/time concentration points may not always give a better definition of the decay curve. On the other hand, the Terminal HL of NCA is deeply affected by the goodness of the last two-three points. The quite long Kedrion FIX HL may allow for a cost/effective tailoring of prophylaxis in haemophilia B patients. |
| Databáze: | OpenAIRE |
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