Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients
- Registration Number
- NCT06574984
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 900
- 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
- Patients diagnosed with coagulation disorders other than haemophilia A such as Von Willebrand disease
- Patients with documented presence of any FVIII inhibitor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Turoctocog alfa Turoctocog alfa Participants received turoctocog alfa intravenously.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Dose of turoctocog alfa At month 12 after switching to turoctocog alfa Measured as international uniit per kilogram (IU/kg).
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.
New target joint At month 12 after switching to turoctocog alfa Measured as number resolution (Yes/No) affected joints.
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.
Haemostatic response to turoctocog alfa At baseline and at month 12 Measured as excellent, good, moderate, none.
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.
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).
Severity of bleeding At month 12 after switching to turoctocog alfa Measured as mild / moderate / severe.
Trial Locations
- Locations (5)
National centre for Hamophilia
🇮🇶Baghdad, Iraq
Basrah Haemoplhilia centre
🇮🇶Basrah, Iraq
Hilla Haemophilia centre
🇮🇶Hilla, Iraq
Karbala Haemophilia centre
🇮🇶Karbala, Iraq
Novo Nordisk Investigational Site
🇮🇶Baghdad, Iraq