The study has descriptive purposes, with aim of assessing how turoctocog alfa is used in the everyday practice and to provide a baseline for the management of haemophilia A and does not involve any change in the clinical management of participants. Data will be extrapolated from the existing paper based medical records and uploaded to an electronic database specifically created for the study. Baseline information/history will be recorded at time of switching from previous FVIII replacement therapy to turoctocog alfa from the enrolled participants and outcomes will be collected according to participants visit format.
Study Type
OBSERVATIONAL
Enrollment
329
Turoctocog alfa was administered intravenously.
National centre for Hamophilia
Baghdad, Iraq
Novo Nordisk Investigational Site
Baghdad, Iraq
Basrah Haemoplhilia centre
Basra, Iraq
Hilla Haemophilia centre
Hillah, Iraq
Karbala Haemophilia centre
Karbala, Iraq
Kirkuk Centre for Cancer and Blood Disorders
Kirkuk, Iraq
Najaf Haemophilia Centre
Najaf, Iraq
Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy
Measured as count of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12.
Time frame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
ABRs among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy
Measured as number of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12 across 4 age segments ( less than \[\<\] 8 years, 8-14 years, 15-18 years, greater than \[\>\] 18 years).
Time frame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Change of primary prophylaxis regimen
Measured as Yes/No.
Time frame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Dose of turoctocog alfa
Measured as international uniit per kilogram (IU/kg).
Time frame: At month 12 after switching to turoctocog alfa
Haemostatic response to turoctocog alfa
Measured as excellent, good, moderate, none.
Time frame: At baseline and at month 12
Spontaneous ABR
Measured as number of reported spontaneous bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12.
Time frame: At month 12 after switching to turoctocog alfa
Annualized joint bleed rate (AJBR)
Measured as number of reported joint bleeding episodes divided by the observation period in months multiplied by 12.
Time frame: At month 12 after switching to turoctocog alfa
New target joint
Measured as number resolution (Yes/No) affected joints.
Time frame: At month 12 after switching to turoctocog alfa
Severity of bleeding
Measured as mild / moderate / severe.
Time frame: At month 12 after switching to turoctocog alfa
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