Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
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.
Interventions
DRUGTuroctocog alfa
Turoctocog alfa was administered intravenously.
Sponsors
Novo Nordisk A/S
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Paediatric and adult male patients * On-demand and prophylactic patients with haemophilia A (any severity) * Only previously treated patients (previous FVIII replacement therapy) will be included in the study
Exclusion criteria
* Patients diagnosed with coagulation disorders other than haemophilia A such as Von Willebrand disease * Patients with documented presence of any FVIII inhibitor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy | From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ABRs among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy | From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa | 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). |
| Change of primary prophylaxis regimen | From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa | Measured as Yes/No. |
| Dose of turoctocog alfa | At month 12 after switching to turoctocog alfa | Measured as international uniit per kilogram (IU/kg). |
| Haemostatic response to turoctocog alfa | At baseline and at month 12 | Measured as excellent, good, moderate, none. |
| Spontaneous ABR | At month 12 after switching to turoctocog alfa | 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. |
| Annualized joint bleed rate (AJBR) | At month 12 after switching to turoctocog alfa | Measured as number of reported joint bleeding episodes divided by the observation period in months multiplied by 12. |
| New target joint | At month 12 after switching to turoctocog alfa | Measured as number resolution (Yes/No) affected joints. |
| Severity of bleeding | At month 12 after switching to turoctocog alfa | Measured as mild / moderate / severe. |
Countries
Iraq
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed