. 2020 Mar 12;38(5):1580–1587. doi: 10.1007/s10637-020-00914-5

Table 5.

Hemostatic parameters post-infusion of dDAVP

Dose^a	VWF:Ag (%)^b Ref: 50–150	VWF:RCo (%)^b Ref: 50–150	FVIII:C (%)^b Ref: 50–150	APTT (seconds)^b Ref: 37–48	ELT (minutes)^b Ref: 90–240
0.25 µg/kg	167 ± 16.8	268 ± 28.1^*	110 ± 11.4	156 ± 19.1^**	115 ± 22.3	142 ± 30.7^**	40 ± 2.7	37 ± 4.2	198 ± 31.0	134 ± 43.4
0.5 µg/kg 1.0 µg/kg	117 ± 14.2 143 ± 36.7	266 ± 19.0^* 309 ± 80.5^*	83 ± 5.8 123 ± 36.4	170 ± 12.7^*** 205 ± 33.0^*	67 ± 8.4 106 ± 18.5	134 ± 17.1^*** 276 ± 53.6^*	61 ± 9.4 44 ± 3.0	43 ± 1.6^* 31 ± 3.1^	194 ± 16.2 208 ± 56.5	41 ± 5.3^* 40 ± 15.2^

Dose^a

VWF:Ag (%)^b
Ref: 50–150

VWF:RCo (%)^b
Ref: 50–150

FVIII:C (%)^b
Ref: 50–150

APTT (seconds)^b
Ref: 37–48

ELT (minutes)^b
Ref: 90–240

Initial

Post dDAVP

Initial

Post dDAVP

Initial

Post dDAVP

Initial

Post dDAVP

Initial

Post dDAVP

0.25 µg/kg

167 ± 16.8

268 ± 28.1^*

110 ± 11.4

156 ± 19.1^**

115 ± 22.3

142 ± 30.7^**

40 ± 2.7

37 ± 4.2

198 ± 31.0

134 ± 43.4

0.5 µg/kg

1.0 µg/kg

117 ± 14.2

143 ± 36.7

266 ± 19.0^***

309 ± 80.5^***

83 ± 5.8

123 ± 36.4

170 ± 12.7^***

205 ± 33.0^*

67 ± 8.4

106 ± 18.5

134 ± 17.1^***

276 ± 53.6^*

61 ± 9.4

44 ± 3.0

43 ± 1.6^***

31 ± 3.1^**

194 ± 16.2

208 ± 56.5

41 ± 5.3^***

40 ± 15.2^**

^aDose level groups 1 + 2 (0.25 µg/kg) and dose level group 3 + expansion cohort group (0.5 µg/kg) are presented together, since in both cases patients received the same dose in the first infusion. Dose level group 4 (1.0 µg/kg) corresponds to the highest dose level analyzed, since the two patients included in dose level group 5 rapidly developed SAE and samples were not available for analysis of hemostatic parameters. ^bVWF:Ag, VWF:RCo, FVIII:C, APTT and ELT were measured immediately before (initial) and 60 minutes after administration of the first intravenous treatment infusion (post dDAVP). The normal reference ranges (Ref) are presented for each parameter. In all cases, data represent mean ± SEM. *P < 0.05, **P < 0.01 and ***P < 0.001 vs the respective initial value (paired t test).