Descriptive Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients - An Observational Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 329
- Locations
- 11
- Primary Endpoint
- Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Male
- Accepts 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
Arms & Interventions
Turoctocog alfa
Participants received turoctocog alfa intravenously.
Intervention: Turoctocog alfa (Drug)
Outcomes
Primary Outcomes
Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy
Time Frame: 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 Outcomes
- Dose of turoctocog alfa(At month 12 after switching to turoctocog alfa)
- Spontaneous ABR(At month 12 after switching to turoctocog alfa)
- New target joint(At month 12 after switching to turoctocog alfa)
- Annualized joint bleed rate (AJBR)(At month 12 after switching to turoctocog alfa)
- Haemostatic response to turoctocog alfa(At baseline and at month 12)
- Change of primary prophylaxis regimen(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(From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa)
- Severity of bleeding(At month 12 after switching to turoctocog alfa)