Trial Outcomes & Findings for Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII (NCT NCT00543439)

Last Updated: 2019-01-11

Results Overview

ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

66 participants

Primary outcome timeframe

Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Results posted on

2019-01-11

Participant Flow

Participants for 1 of the sites, were excluded from efficacy and safety analysis due to data integrity issues, however were reported in participant flow and baseline analysis.

Participant milestones

Participant milestones
Measure	Moroctocog Alfa (AF-CC),OD Cohort:OD Therapy Then RP Therapy Participants who consented for pharmacokinetic assessment received single 50 international units per kilogram \[IU/kg\] infusion of AF-CC on Day 1 prior start of study treatment.Period 1:participants were treated with on-demand (OD) therapy intravenous (IV) infusion of AF-CC for 6 months(Day 1 up to Month 6)prescribed by investigator based on current recommendations for OD therapy with licensed product Xyntha (Minor bleeding:repetition of IV infusion of AF-CC,20-40 IU/kg,every 12-24 hours (hr) until resolved for at least 1 day,depending upon severity of bleeding episode;Moderate bleeding:repetition of IV infusion of AF-CC,30-60 IU/kg,every 12-24 hr for 3-4 days/until adequate local hemostasis achieved;Major bleeding:repetition of IV infusion of AF-CC,60-100 IU/kg,every 8-24 hr until bleeding resolved).Then in Period 2 participants received IV infusion of AF-CC at 25 IU/kg once in 2 days up to 12 months (Month 7 to Month 18) as RP therapy and if required were treated with OD IV infusion.	Moroctocog Alfa(AF-CC),RP Cohort:RP 25 IU/kg Then RP 45IU/kg Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.	Moroctocog Alfa(AF-CC), RP Cohort:RP 45 IU/kg Then RP25IU/kg Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg twice per week up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.
Period 1 STARTED	10	29	27
Period 1 Treated	9	29	27
Period 1 COMPLETED	9	26	25
Period 1 NOT COMPLETED	1	3	2
Period 2 STARTED	9	26	25
Period 2 COMPLETED	8	25	23
Period 2 NOT COMPLETED	1	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Moroctocog Alfa (AF-CC),OD Cohort:OD Therapy Then RP Therapy Participants who consented for pharmacokinetic assessment received single 50 international units per kilogram \[IU/kg\] infusion of AF-CC on Day 1 prior start of study treatment.Period 1:participants were treated with on-demand (OD) therapy intravenous (IV) infusion of AF-CC for 6 months(Day 1 up to Month 6)prescribed by investigator based on current recommendations for OD therapy with licensed product Xyntha (Minor bleeding:repetition of IV infusion of AF-CC,20-40 IU/kg,every 12-24 hours (hr) until resolved for at least 1 day,depending upon severity of bleeding episode;Moderate bleeding:repetition of IV infusion of AF-CC,30-60 IU/kg,every 12-24 hr for 3-4 days/until adequate local hemostasis achieved;Major bleeding:repetition of IV infusion of AF-CC,60-100 IU/kg,every 8-24 hr until bleeding resolved).Then in Period 2 participants received IV infusion of AF-CC at 25 IU/kg once in 2 days up to 12 months (Month 7 to Month 18) as RP therapy and if required were treated with OD IV infusion.	Moroctocog Alfa(AF-CC),RP Cohort:RP 25 IU/kg Then RP 45IU/kg Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.	Moroctocog Alfa(AF-CC), RP Cohort:RP 45 IU/kg Then RP25IU/kg Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg twice per week up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.
Period 1 Adverse Event	0	2	1
Period 1 Withdrawal by Subject	1	1	0
Period 1 Physician Decision	0	0	1
Period 2 Protocol Violation	1	0	1
Period 2 Adverse Event	0	1	1

Baseline Characteristics

Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moroctocog Alfa (AF-CC),OD Cohort:OD Therapy Then RP Therapy n=9 Participants Participants who consented for pharmacokinetic assessment received single 50 international units per kilogram \[IU/kg\] infusion of AF-CC on Day 1 prior start of study treatment.Period 1:participants were treated with on-demand (OD) therapy intravenous (IV) infusion of AF-CC for 6 months(Day 1 up to Month 6)prescribed by investigator based on current recommendations for OD therapy with licensed product Xyntha (Minor bleeding:repetition of IV infusion of AF-CC,20-40 IU/kg,every 12-24 hours (hr) until resolved for at least 1 day,depending upon severity of bleeding episode;Moderate bleeding:repetition of IV infusion of AF-CC,30-60 IU/kg,every 12-24 hr for 3-4 days/until adequate local hemostasis achieved;Major bleeding:repetition of IV infusion of AF-CC,60-100 IU/kg,every 8-24 hr until bleeding resolved).Then in Period 2 participants received IV infusion of AF-CC at 25 IU/kg once in 2 days up to 12 months (Month 7 to Month 18) as RP therapy and if required were treated with OD IV infusion.	Moroctocog Alfa(AF-CC),RP Cohort:RP 25 IU/kg Then RP 45IU/kg n=29 Participants Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg, twice per week up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.	Moroctocog Alfa(AF-CC), RP Cohort:RP 45 IU/kg Then RP25IU/kg n=27 Participants Participants received a single 50 IU/kg infusion of moroctocog alfa (AF-CC) on Day 1 before initiation of moroctocog alfa (AF-CC) study treatment either in on demand cohort or routine prophylaxis cohort. In Period 1 participants for routine prophylaxis therapy, received IV infusion of moroctocog alfa (AF-CC) at 45 IU/kg twice per week up to 12 months (Day 1 up to Month 12). Period 1 was followed by Period 2 where participants received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months (Month 13 up to Month 24) as routine prophylaxis therapy. Participants were treated OD IV infusion up to 12 months.	Total n=65 Participants Total of all reporting groups
Age, Continuous	4.7 years STANDARD_DEVIATION 1.05 • n=5 Participants	4.4 years STANDARD_DEVIATION 1.84 • n=7 Participants	4.1 years STANDARD_DEVIATION 2.28 • n=5 Participants	4.3 years STANDARD_DEVIATION 1.94 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	24 Participants n=7 Participants	22 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Population: Intent-to-treat (ITT) analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=9 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=8 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean Annualized Bleed Rate (ABR) by Treatment: On Demand Cohort	47.0 Bleeds per year Standard Deviation 32.2	1.5 Bleeds per year Standard Deviation 2.2	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, Period 1 and Period 2)

Population: ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=38 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=38 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean Annualized Bleed Rate (ABR) by Treatment: Routine Prophylaxis Cohort	3.3 Bleeds per year Standard Deviation 5.3	2.2 Bleeds per year Standard Deviation 4.1	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24

In this outcome measure, the mean of total number of moroctocog alfa (AF-CC) on-demand infusions administered to treat each bleeding episode was reported, regardless of participant cohort or period during which it occurred.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=562 bleed In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean of Moroctocog Alfa (AF-CC) Infusions Administered To Treat Bleeding Episode: All Participants	1.5 Infusions Standard Deviation 1.38	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24

Number (no.) of bleeds treated are reported on basis of response to first infusion of study drug, at 4-point scale: excellent, good, moderate, no response. Excellent:definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good:definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate:probable or slight improvement starting after 8 hr following infusion,at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as:Data Not Recorded. Total no. of first infusions may not be equal to total no. of bleeds if bleed was: missing start date/dose information or treated initially with non-study FVIII.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=559 bleeds In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort) Good	150 Bleeds	—	—	—
Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort) Moderate	27 Bleeds	—	—	—
Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort) No Response	2 Bleeds	—	—	—
Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort) Excellent	376 Bleeds	—	—	—
Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort) Data Not Recorded	4 Bleeds	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form and who reported a spontaneous bleeding episode following a routine prophylaxis dose.

In this outcome measure number of treated spontaneous bleeds are reported according to the time interval between bleed onset and prior moroctocog alfa (AF-CC) routine prophylaxis dose. Following time intervals used to report this outcome measure: lesser than or equal to (\<=) 24 hours, greater than (\>) 24 hours to \<=48 hours, \>48 hours to \<=72 hours, \>72 hours. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg" cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=28 bleeds In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=18 bleeds In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy >72 hours	13 Bleeds	7 Bleeds	—	—
Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy <=24 hours	1 Bleeds	3 Bleeds	—	—
Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy >24 hours to <=48 hours	4 Bleeds	6 Bleeds	—	—
Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy >48 hours to <=72 hours	10 Bleeds	2 Bleeds	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

During prophylaxis, criteria for prophylaxis regimen escalation are the occurrence, over a 4-week duration (and in the absence of a confirmed FVIII inhibitor), of (a) 2 or more spontaneous bleeds into a major joint and/or target joint, or (b) 3 or more spontaneous bleeds (consisting of joint bleeds and/or significant soft tissue/muscle or other site bleeds). If either criterion was met, the participant was escalated to a more intense prophylaxis regimen of 45 IU/kg, administered every other day. Participant who meet dose escalation criteria while on prophylaxis regimen of 45 IU/kg, were escalated to a higher intensity regimen designated by the investigator. Significant spontaneous bleeds were those that led to a transient or persistent loss of function. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=39 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=48 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Participants Requiring Prophylaxis Regimen Escalation: Routine Prophylaxis Therapy	2 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Mean RP dose (by weight) for each participant was calculated as his total moroctocog alfa (AF-CC) consumption (in IU) divided by weight (in kg). For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=8 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=39 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg n=40 Participants Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg n=48 Participants Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean Routine Prophylaxis Dose (IU/kg) of Moroctocog Alfa (AF-CC) Received: Routine Prophylaxis Therapy	25 IU/kg Standard Deviation 4.6	46 IU/kg Standard Deviation 5.8	26 IU/kg Standard Deviation 5.4	26 IU/kg Standard Deviation 5.2

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

In this outcome measure mean of total number of infusions of moroctocog alfa (AF-CC) received by participant is reported. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=8 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=39 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg n=40 Participants Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg n=48 Participants Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean of Total Number Moroctocog Alfa (AF-CC) Infusions Received: Routine Prophylaxis Therapy	170 Infusions Standard Deviation 31.3	91 Infusions Standard Deviation 22.4	150 Infusions Standard Deviation 37.0	154 Infusions Standard Deviation 36.6

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=8 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=39 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg n=40 Participants Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg n=48 Participants Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean of Total Number of Days Participants Exposed to Moroctocog Alfa (AF-CC): Routine Prophylaxis Therapy	170 Days Standard Deviation 31.3	91 Days Standard Deviation 22.3	150 Days Standard Deviation 37.0	153 Days Standard Deviation 36.5

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Participants' compliance to their assigned prophylaxis regimen was measured by following: a) number of infusions received per week and b) dose received. In this outcome measure mean of total number of infusions of moroctocog alfa (AF-CC) received by participants per week is reported. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg" cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=39 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=48 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean of Total Number of Infusions of Moroctocog Alfa (AF-CC) Received Per Week to Assess Compliance: Routine Prophylaxis Therapy	2.1 Infusions per week Standard Deviation 0.81	3.3 Infusions per week Standard Deviation 0.18	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single pharmacokinetic (PK) assessment at the start of the study and for whom an adequate PK profile had been obtained.

Plasma decay half-life is the time measured for the FVIII activity to decrease by one half.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Terminal Phase Half Life (t1/2) of Factor VIII (FVIII) Activity	8.86 Hour Standard Deviation 2.3513	—	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.

Clearance is a measure of the volume of plasma from which FVIII activity is removed per unit time. It was reported in units milliliter per hour per kilogram (mL/hr/kg).

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Clearance (CL) of Factor VIII Activity	5.822 mL/hr/kg Geometric Coefficient of Variation 59	—	—	—

SECONDARY outcome

Timeframe: Day 1, Month 6

Population: Analysis population included all participants for whom legal acceptable representative had signed informed consent/assent form, were in non-bleeding state, participated in single PK assessment at start of study and for whom an adequate PK profile had been obtained. "Number analyzed" signifies participants evaluable at specified time points.

Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of moroctocog alfa (AF-CC) administered per kilogram of body weight of participant. It was measured in international units per deciliter per international units per kilogram (\[IU/dL\]/\[IU/kg\]).

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Incremental Recovery of Factor VIII Activity Day 1	1.4438 (IU/dL)/(IU/kg) Standard Deviation 0.6145	—	—	—
Incremental Recovery of Factor VIII Activity Month 6	1.4148 (IU/dL)/(IU/kg) Standard Deviation 0.4046	—	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.

Maximum concentration of FVIII activity was measured in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Maximum Concentration of Factor VIII Activity	0.7005 IU/mL Geometric Coefficient of Variation 60	—	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.

Area under FVIII activity-time profile from time zero extrapolated to infinite time. AUCinf is reported in units: international units\*hour per milliliter (IU\*hour/mL).

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Factor VIII Activity	9.02 IU*hr/mL Geometric Coefficient of Variation 50	—	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.

Area under the FVIII activity -versus-time curve from time zero to the time of the last quantifiable concentration.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) of Factor VIII Activity	8.04 IU*hr/mL Geometric Coefficient of Variation 46	—	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.

Volume of distribution is defined as the theoretical volume in which the total amount of FVIII would need to be uniformly distributed to produce the observed plasma concentration of FVIII. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Steady-State Volume of Distribution (Vss) of Factor VIII Activity	78.38 Milliliter per kilogram Geometric Coefficient of Variation 50	—	—	—

SECONDARY outcome

Timeframe: 0.5, 8, 24, 28 and 32 hours post dose on Day 1

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.

MRT was calculated as AUMCinf /AUCinf-TI/2, where AUMCinf is the area under the moment curve from time zero to infinity and TI is the duration of infusion.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=7 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Mean Residence Time (MRT) of Factor VIII Activity	13.46 Hour Geometric Coefficient of Variation 33	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 25

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form and were analyzed for safety. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AE is untoward medical occurrence in clinical investigation participant administered product or medical device;event need not necessarily had causal relationship with treatment or usage.Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 25 months)that were absent before treatment or that worsened relative to pretreatment state.AEs were classified into following on basis of severity:1)mild = did not interfere with participant's usual function;2)moderate=interfered to some extent with participant's usual function;3)severe=interfered significantly with participant's usual function;4)life threatening=AE required discontinuation of study drug,participant was at immediate risk of death.All participants in study received AF-CC.AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis,regardless of regimen were following at time,regardless of OD or RP cohort.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=49 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity Mild	12 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity Moderate	29 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity Severe	8 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity Life threatening	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 25

Population: Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form and were analyzed for safety.

A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. All participants in the study received moroctocog alfa-(AF-CC). Adverse events were not collected separately for each intervention for the participants. All participants were properly combined for the analysis and was regardless of the regimen they were following at the time, and regardless of OD or RP cohort.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=51 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Participants With Treatment-Related Adverse Events	49 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24

Population: Analysis population included all participants for whom legal acceptable representative had signed informed consent/assent form and who received 1 dose of moroctocog alfa (AF-CC) and were at risk for confirmed FVIII inhibitor development.

Confirmed FVIII inhibitors were defined as a neutralizing antibody to FVIII with a titer value of greater than or equal to (\>=) 0.6 Bethesda units (BU) per millimeter in a sample assayed using the Nijmegen assay at the central laboratory.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=49 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Participants With Confirmed FVIII Inhibitor Development	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

LETE occurs in OD setting if participant recorded 2 successive "No Response" (no improvement at all between infusions, or condition worsens) ratings after 2 successive infusions of study drug. Infusions must have been given within 24 hours (hr) of each other for treatment of same bleeding event in absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of \>4 hr between onset of bleed to infusion, delay of \>24 hr before administration of a follow-up infusion, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator. For reporting arm: "Moroctocog alfa (AF-CC), OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=9 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=42 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg n=51 Participants Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): On Demand Therapy	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

LETE in prophylaxis setting if there was a spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of study drug (which was not used to treat a bleed) in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose \[a dose less than that prescribed in participant's regimen\], known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for the bleed in the opinion of the investigator. Therefore, LETE in the prophylaxis setting was the occurrence of a bleed. For reporting arm: "Moroctocog alfa (AF-CC), OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported.

Outcome measures

Outcome measures
Measure	Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy n=42 Participants In Period 1, participants for on-demand therapy were treated with IV infusion of moroctocog alfa (AF-CC) for 6 months (Day 1 up to Month 6) as prescribed by the investigator based on current recommendations for on-demand treatment with licensed product Xyntha (Minor bleeding: repetition of IV infusion of Moroctocog alfa, 20-40 IU/kg, every 12-24 hours as necessary until resolved for at least 1 day, depending upon severity of bleeding episode; Moderate bleeding: repetition of IV infusion of Moroctocog alfa, 30-60 IU/kg, every 12-24 hours for 3-4 days or until adequate local hemostasis was achieved; Major bleeding: repetition of IV infusion of moroctocog alfa (AF-CC), 60-100 IU/kg, every 8-24 hours until bleeding was resolved).	Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg n=51 Participants In Period 2, participants for on-demand cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg once in 2 days up to 12 months (Month 7 up to Month 18) as routine prophylaxis therapy.	Moroctocog Alfa (AF-CC), RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study.	Moroctocog Alfa(AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg Participants of routine prophylaxis cohort received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days up to 12 months as routine prophylaxis therapy each for either Period 1 (Day 1 up to Month 12) or Period 2 (Month 13 up to Month 24) of the study. And participants of on demand cohort for Period 2 of the study, received IV infusion of moroctocog alfa (AF-CC) at 25 IU/kg, once in 2 days as routine prophylaxis therapy up to 12 months (Month 7 up to Month 18).
Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): Routine Prophylaxis Therapy	3 Participants	5 Participants	—	—

Adverse Events

Moroctocog Alfa (AF-CC): All Participants

Serious events: 13 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Moroctocog Alfa (AF-CC): All Participants n=51 participants at risk All participants who received moroctocog alfa-(AF-CC) 50 IU/kg for PK assessment on Day 1 prior start of study treatment and as on demand or routine prophylaxis treatment (25 and 45 IU/kg).
Musculoskeletal and connective tissue disorders Haemarthrosis	3.9% 2/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	3.9% 2/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Torticollis	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Blood and lymphatic system disorders Factor VIII inhibition	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Device related infection	3.9% 2/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Limb injury	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Post procedural haemorrhage	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Abdominal pain	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Immune system disorders Drug hypersensitivity	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Nervous system disorders Monoplegia	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Nervous system disorders Seizure	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Vascular disorders Haematoma	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
General disorders Catheter site rash	2.0% 1/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.

Other adverse events

Other adverse events
Measure	Moroctocog Alfa (AF-CC): All Participants n=51 participants at risk All participants who received moroctocog alfa-(AF-CC) 50 IU/kg for PK assessment on Day 1 prior start of study treatment and as on demand or routine prophylaxis treatment (25 and 45 IU/kg).
Infections and infestations Upper respiratory tract infection	31.4% 16/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Nasopharyngitis	27.5% 14/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Influenza	15.7% 8/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Tonsillitis	13.7% 7/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Pharyngitis	9.8% 5/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Varicella	7.8% 4/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Infections and infestations Viral infection	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
General disorders Pyrexia	47.1% 24/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
General disorders Fatigue	7.8% 4/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Joint injury	19.6% 10/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Limb injury	19.6% 10/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Head injury	13.7% 7/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Contusion	9.8% 5/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Fall	9.8% 5/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Face injury	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Laceration	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Injury, poisoning and procedural complications Traumatic haematoma	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Vomiting	19.6% 10/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Diarrhoea	13.7% 7/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Abdominal pain	11.8% 6/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Toothache	11.8% 6/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Abdominal pain upper	9.8% 5/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Gastrointestinal disorders Tooth loss	7.8% 4/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Respiratory, thoracic and mediastinal disorders Cough	29.4% 15/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	13.7% 7/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Arthralgia	19.6% 10/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	19.6% 10/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Back pain	7.8% 4/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Musculoskeletal and connective tissue disorders Haemarthrosis	7.8% 4/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Nervous system disorders Headache	13.7% 7/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Surgical and medical procedures Tooth extraction	5.9% 3/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.8% 5/51 • Day 1 up to Month 25 Same event may appear both an AE and SAE.However,what is presented are distinct events.An event may be categorized as serious in 1 participant and as non-serious in another,or participant may have experienced both SAE and NSAE.All participants in study received moroctocog alfa(AF-CC).AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis and was regardless of regimen they were following at time,regardless of OD or RP cohort.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER