A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
Unnamed facility
Kirov, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Saint Petersburg, Russia
Unnamed facility
Yekaterinburg, Russia
Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Bleeds Per Participant During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Participants With Bleeding Events During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Participants With Joint Bleeds During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Participants in Each Group at the End of the Study
Time frame: Up to 9 months
Actual Monthly rFVIII-FS Consumption
Time frame: Up to 9 months
Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment
The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).
Time frame: baseline and 9 months
Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)
Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).
Time frame: 9 months
Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment
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rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for patients in this group
Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).
Time frame: 9 months