Figure 1.
PROPEL study design. Design of this phase 3, prospective, randomized, open-label, multicenter clinical study (#NCT02585960); initiated November 2015, completed August 2018. *In the Nijmegen modification of the Bethesda assay. †Randomization occurred after the PK assessment and was stratified according to patients’ prestudy treatment regimen and ABR (prophylaxis with ABR <5 vs prophylaxis with ABR ≥5 vs on-demand) independent of their individual characteristics (ie, PK profile, activity level, or bleeding activity). ‡Prophylactic dose and dosing frequency with rurioctocog alfa pegol were based on the patient’s individual PK assessment and could be adjusted to maintain the target FVIII trough level on the basis of FVIII assessments at each study visit during the first 6-month study period.

PROPEL study design. Design of this phase 3, prospective, randomized, open-label, multicenter clinical study (#NCT02585960); initiated November 2015, completed August 2018. *In the Nijmegen modification of the Bethesda assay. †Randomization occurred after the PK assessment and was stratified according to patients’ prestudy treatment regimen and ABR (prophylaxis with ABR <5 vs prophylaxis with ABR ≥5 vs on-demand) independent of their individual characteristics (ie, PK profile, activity level, or bleeding activity). ‡Prophylactic dose and dosing frequency with rurioctocog alfa pegol were based on the patient’s individual PK assessment and could be adjusted to maintain the target FVIII trough level on the basis of FVIII assessments at each study visit during the first 6-month study period.

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