Positioning extended half-life concentrates for future use: a practical proposal

Note: Funding Information: This letter is written on behalf of the international multicentre study “OPTI-CLOT” (Patient tailO red P harmacokineTIc-guided dosing of CLOTting factor concentrate in bleeding disorders) that aims to implement a PK-guided approach in treatment of bleeding disorders using population PK models for DDAVP and factor concentrates. “OPTI-CLOT” study group members are: Steering committee—M.H. Cnossen (principal investigator and chair), Erasmus University Medical Centre—Sophia Children’ s Hospital, Rotterdam; F.W.G. Leebeek, Erasmus University Medical Centre, Rotterdam; K. Fijnvandraat, R.A.A. Mathôt, Amsterdam University Medical Centre, Amsterdam; K. Meijer, University Medical Centre Groningen, Groningen. Principal Investigators and Local Collaborators in the Netherlands—M.J.A.H. Kruip, S. Polinder, J. Lock, H.C.A.M. Hazendonk, I. van Moort, J.M. Heijdra, A. Nederlof, Erasmus University Medical Centre, Rotterdam; T. Preijers, N. de Jager, M. Coppens, Amsterdam University Medical Centre, Amsterdam; K. Meijer, R.Y.J. Tamminga, University Medical Centre Groningen, Groningen; P. Brons, B.A.P. Laros-van Gorkom, Radboud University Medical Centre, Nijmegen; F.J.M. van der Meer, H.C.J. Eikenboom, Leids University Medical Centre, Leiden; R.E.G. Schutgens, K. Fischer, University Medical Centre Utrecht, Utrecht; E.A.M. Beckers, Maastricht University Medical Centre , Maastricht; L. Nieuwenhuizen, Maxima Medical Centre, Eindhoven; M.H.E. Driessens, Dutch Haemophilia Patient Society; Website, Trialbureau and Databases—C.M. Zwaan, I. van Vliet, Erasmus University Medical Centre, Rotterdam. Principal Investigators and Local Collaborators in the United Kingdom—P.W. Collins, Arthur Bloom Haemophilia Centre, Institute of infection and immunity, School of Medicine, Cardiff University, Cardiff; R. Liesner, Great Ormond Street Haemophilia Centre, Great Ormond Street Hospital for Children NHS Trust, London; P. Chowdary, Katharine Dormandy Haemophilia Centre and Thrombosis Unit, Royal Free London NHS Foundation Trust, London; C.M. Millar, Hammersmith Hospital-Imperial College Healthcare NHS Trust, London; D. Hart, Department of Haematology, The Royal London Hospital Barts Health NHS Trust, London; D. Keeling, Oxford Haemophilia and Thrombosis Centre, Oxford University Hospitals, Churchill Hospital, Oxford. Dr. M.H. Cnossen has received unrestricted research grants for investigator-initiated studies and travel grants from NWO-ZonMW, the Dutch “Innovatiefonds,” Pfizer, Shire, Bayer, Novo Nordisk, Nordic Pharma, Novartis, CSL Behring and Roche and is consultant for Roche and Bayer of which payments go to the institution. Dr. K. Fischer has received speaker’ s fees from Bayer, Baxter, Biotest, CSL Behring, Biotest Octapharma, Pfizer and Novo Nordisk; performed consultancy for Bayer, Baxter, Biogen, CSL Behring, Freeline, Novo Nordisk, Pfizer, Roche and SOBI; and has received research support from Bayer, Pfizer, Baxter and Novo Nordisk. Prof. Dr. R.A.A. Mathôt has received unrestricted research grants for investigator-initiated studies from Bayer and Merck. Prof. Dr. F.W.G. Leebeek received unrestricted research grants from CSL Behring and Shire outside the submitted work and is consultant for Shire, UniQure and Novo Nordisk (DSMB), of which payments go to the institution. The institution of Prof. Dr. K. Fijnvandraat has received unrestricted research grants from CSL Behring, Bayer and Novo Nordisk and her institution received consultancy fees from Shire, Novo Nordisk and Bayer. MSc. A. Nederlof has no financial interests to declare.