107 Systematic review on PK of emicizumab Table 1. Study characteristics. In order of study phase. 1st Author (study name) Year of publication n = Study phase Study country Multicenter Openlabel Randomized Controlled Parallel comparison Study design Population FVIII inhibitor Dosing regimen Follow-up period Industry fundeda Uchida N. 2016 64 I Japan - - + + - RCT, doseescalation Volunteer NA SSI 4, 16, 20 or 24 weeks + Shima M. 2016 18 I Japan + + - - +, Intraindividual CT, doseescalation PwHA +, - QW 12 weeks + Shima M. 2017 16 I/II Japan + + - - +, Intraindividual CT, consecutive study PwHA +, - QW Until median >2 year + Kotani N. 2019 60 I Japan - + + - + RCT Volunteer NA SSI, SII 16 weeks + Li H. 2020 16 I China - + - - - CT Volunteer NA SSI 16 weeks + Yoneyama K. 2018 60 NA NA NA NA NA NA NA PK Analysis PwHA, Volunteer +, - SSI, QW NA + Oldenburg J. (HAVEN 1) 2017 109 III Global + + + + +, Intraindividual RCT PwHA + QW >24 weeks + Schmitt C. (HAVEN 1) 2020 112 III Global + + + + +, Intraindividual RCT, consecutive study PwHA + QW 61 weeks (median) + Young G. (HAVEN 2) 2019 88 III Global + + - - +, Intraindividual CT PwHA, child + QW, Q2W, Q4W >52 weeks + Mahlangu J. (HAVEN 3) 2018 152 III Global + + + + +, Intraindividual RCT PwHA - QW, Q2W >24 weeks + Pipe S.W. (HAVEN 4) 2019 48 III Global + + - - - CT, twostage PwHA +, - Q4W >24 weeks + Shima M. (HOHOEMI) 2019 13 III Japan + + - - + CT PwHA, child - Q2W, Q4W >24 weeks + 6
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