Long-Term Safety of PEGylated Coagulation Factor VIII in the Immune-Deficient Rowett Nude Rat
Table 5
Mean activated partial thromboplastin time—percentage deviation from controls (antibody-positive animals excluded) in the 26- and 52-week studies (the mean activated partial thromboplastin time in control animals across studies is ~16 seconds).
(a) 26 Weeks
Group
N8-GP (IU/kg)
Dosing phase, week 13
Dosing phase, week 26
Males
Females
Males
Females
2
50
−13
+1
−3
−6
3
150
−17
−2
−13
−14
4
500
−19
−6
−22
−16
5
1200
−30
−13
−30
−2
(b) 52 weeks
Group
N8-GP (IU/kg)
Dosing phase, week 13
Dosing phase, week 30
Dosing phase, week 48
Males
Females
Males
Females
Males
Females
2
50
−1
−2
+9
+14
+5
−3
3
150
−7
−8
−3
−6
−9
−8
4
500
−27
−16
−13
−18
−29
−13
5
1200
−38
−26
−29
−27
−33
−26
< 0.05; < 0.01; all female 26-week main study animals, blood samples were taken two to four days after last dose and not 12 hours after dose as originally planned.