Page 129 - Haematologica Vol. 107 - September 2022

ARTICLE - Effects of BT200 on VWF/FVIII in humans
K.D. Kovacevic et al.
episodes of minor spontaneous bleeding that occurred in the form of epistaxis and gingival bleeding, and minor pro- voked bleeding in the form of venepuncture-related hematomata. This occurred in one of 24 subjects given 24 mg BT200, and in 5/18 subjects given a 48 mg single-dose of BT200. There was only one healthy volunteer with thrombocytopenia (he received BT200 intravenously). He
had low platelet counts at the start of the trial (142x109/L decreasing to a minimum of 117x109/L), but these normal- ized towards the end of the trial. He also experienced a local hematoma. There was no fall in hemoglobin in any participant.
It is of note that one subject developed venous thrombo- sis and another subject thrombophlebitis at the insertion
Figure 5. Factor VIII activity levels after single doses of BT200. Data are mean values without error bars for better visibility (n=6 for BT200 groups, n=20 for placebo). sc: subcutaneous; inj: injection; inf: infusion.
Figure 6. Factor VIII clotting activity (%) after combined administration of BT200/placebo with desmopressin or BT200/placebo alone. Data are represented as mean values with 95% confidence interval (n=6 for BT200 groups, n=20 for placebo, n=2 for placebo+desmopressin).
Haematologica | 107 September 2022
2128