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.