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Is pharmacokinetic-guided dosing of desmopressin and von Willebrand factor-containing concentrates in individuals with von Willebrand disease or low von Willebrand factor reliable and feasible? A protocol for a multicentre, non-randomised, open label cohort trial, the OPTI-CLOT: to WiN study.
Heijdra JM, Al Arashi W, de Jager NCB, Cloesmeijer ME, Bukkems LH, Zwaan CM, Leebeek FWG, Mathôt RAA, Cnossen MH; OPTI-CLOT Study Group. Heijdra JM, et al. BMJ Open. 2022 Feb 15;12(2):e049493. doi: 10.1136/bmjopen-2021-049493. BMJ Open. 2022. PMID: 35168962 Free PMC article.
Reliability and feasibility of PK-guided dosing will be tested by assessing predictive performance, treatment duration, haemostasis, patient satisfaction and physician satisfaction. ETHICS AND DISSEMINATION: The OPTI-CLOT:to WiN study was approved by the medical eth …
Reliability and feasibility of PK-guided dosing will be tested by assessing predictive performance, treatment duration, haemostasis, patient …
Perioperative pharmacokinetic-guided factor VIII concentrate dosing in haemophilia (OPTI-CLOT trial): an open-label, multicentre, randomised, controlled trial.
van Moort I, Preijers T, Bukkems LH, Hazendonk HCAM, van der Bom JG, Laros-van Gorkom BAP, Beckers EAM, Nieuwenhuizen L, van der Meer FJM, Ypma P, Coppens M, Fijnvandraat K, Schutgens REG, Meijer K, Leebeek FWG, Mathôt RAA, Cnossen MH; OPTI-CLOT study group. van Moort I, et al. Lancet Haematol. 2021 Jul;8(7):e492-e502. doi: 10.1016/S2352-3026(21)00135-6. Lancet Haematol. 2021. PMID: 34171280 Clinical Trial.
METHODS: In this open-label, multicentre, randomised, controlled trial (OPTI-CLOT), patients were recruited from nine centres in Rotterdam, Groningen, Utrecht, Nijmegen, The Hague, Leiden, Amsterdam, Eindhoven, and Maastricht in The Netherlands. ...
METHODS: In this open-label, multicentre, randomised, controlled trial (OPTI-CLOT), patients were recruited from nine centres …
A new population pharmacokinetic model for recombinant factor IX-Fc fusion concentrate including young children with haemophilia B.
Koopman SF, Goedhart TMHJ, Bukkems LH, Mulders TM, Leebeek FWG, Fijnvandraat K, Coppens M, Mathias M, Collins PW, Tait RC, Bagot CN, Curry N, Payne J, Chowdary P, Cnossen MH, Mathôt RAA; OPTI-CLOT study group and SYMPHONY consortium. Koopman SF, et al. Br J Clin Pharmacol. 2024 Jan;90(1):220-231. doi: 10.1111/bcp.15881. Epub 2023 Sep 12. Br J Clin Pharmacol. 2024. PMID: 37567779 Free article.
METHODS: We collected prospective and retrospective data from patients with haemophilia B treated with rFIX-Fc and included in the OPTI-CLOT TARGET study (NTR7523) or United Kindom (UK)-EHL Outcomes Registry (NCT02938156). ...
METHODS: We collected prospective and retrospective data from patients with haemophilia B treated with rFIX-Fc and included in the OPTI …
von Willebrand Factor and Factor VIII Clearance in Perioperative Hemophilia A Patients.
van Moort I, Bukkems LH, Heijdra JM, Schutgens REG, Laros-van Gorkom BAP, Nieuwenhuizen L, van der Meer FJM, Fijnvandraat K, Ypma P, de Maat MPM, Leebeek FWG, Meijer K, Eikenboom J, Mathôt RAA, Cnossen MH; OPTI-CLOT Study Group. van Moort I, et al. Thromb Haemost. 2020 Jul;120(7):1056-1065. doi: 10.1055/s-0040-1710591. Epub 2020 Jun 1. Thromb Haemost. 2020. PMID: 32480417 Clinical Trial.
AIM: To investigate VWF kinetics (VWF antigen [VWF:Ag]), VWF glycoprotein Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp) in severe and moderate perioperative hemophilia A patients included in the randomized controlled perioperative OPTI-CLOT trial. METHODS: Line …
AIM: To investigate VWF kinetics (VWF antigen [VWF:Ag]), VWF glycoprotein Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp) in severe and m …
Does difference between label and actual potency of factor VIII concentrate affect pharmacokinetic-guided dosing of replacement therapy in haemophilia A?
Goedhart TMHJ, Bukkems LH, van Moort I, Spence CC, Zwaan MC, de Maat MPM, Mathôt RAA, Cnossen MH; OPTI-CLOT study group and SYMPHONY consortium. Goedhart TMHJ, et al. Haemophilia. 2022 Jul;28(4):610-618. doi: 10.1111/hae.14575. Epub 2022 May 8. Haemophilia. 2022. PMID: 35526235 Free PMC article. Clinical Trial.
METHODS: We analyzed individual preoperative PK profiling data from severe and moderate haemophilia A patients included in the OPTI-CLOT randomized controlled trial. Label and actual potency were compared, with data on potency provided by pharmaceutical companies. . …
METHODS: We analyzed individual preoperative PK profiling data from severe and moderate haemophilia A patients included in the OPTI- …
Desmopressin testing in von Willebrand disease: Lowering the burden.
Heijdra JM, Atiq F, Al Arashi W, Kieboom Q, Wuijster E, Meijer K, Kruip MJHA, Leebeek FWG, Cnossen MH; OPTI‐CLOT Study Group. Heijdra JM, et al. Res Pract Thromb Haemost. 2022 Sep 26;6(6):e12784. doi: 10.1002/rth2.12784. eCollection 2022 Aug. Res Pract Thromb Haemost. 2022. PMID: 36186107 Free PMC article.
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