This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.
Study Type
OBSERVATIONAL
Enrollment
18
Patients will be treated with commercially available NovoEight® (turoctocog alfa) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available NovoEight® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
Novo Nordisk Investigational Site
Milan, MI, Italy
Novo Nordisk Investigational Site
Bologna, Italy
Novo Nordisk Investigational Site
Castelfranco Veneto, Italy
Novo Nordisk Investigational Site
Catania, Italy
Novo Nordisk Investigational Site
Cesena, Italy
Novo Nordisk Investigational Site
Florence, Italy
Novo Nordisk Investigational Site
Milan, Italy
Novo Nordisk Investigational Site
Naples, Italy
Novo Nordisk Investigational Site
Roma, Italy
Novo Nordisk Investigational Site
Vicenza, Italy
Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)
Count
Time frame: Baseline (week 0)
Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW
Count
Time frame: Final visit (12 months)
Change of PPX regimen: YES/NO
Count (participants who have changed regimen or not)
Time frame: 12 months after treatment initiation
Reported reasons for change of PPX regimens
Count (reasons according to the predefined list, see below) Individual reported reasons for switch will be selected among the following predefined: 1. to improve articular protection 2. due to bleedings 3. due to patients' needs, including: physical inactivity, work, recreational activity, travel, other.
Time frame: Final visit (12 months)
Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire
Points The following sections of the BHERO questionnaire will be used: 1. Haemophilia Activities List (HAL: measures the impact of haemophilia on self-perceived functional abilities in patients (42 questions in 7 domains). Scores from 1 (worst) to 6 (best). The final score is the sum of all the scores.) 2. Recreational and sport activities 3. Brief pain inventory, exploring the presence and intensity of physical pain, and its impact on performance of daily activities. 4. International Physical Activities questionnaire (IPAQ) score (Score\<700 = Inactive Patient, Score 700 to 2519 = Sufficiently active patient, Score ≥ 2520 = Active or very active patient.
Time frame: Final visit (12 months) vs Baseline (week 0)
Difference in circulating turoctocog alfa levels
IU/mL Before 12 months visit, monitoring will be reported only if measured in clinical practice due to bleedings or other clinical reasons.
Time frame: Final visit (12 months) vs Baseline (week 0)
Individual Annual Bleeding Rate (ABR)
Count
Time frame: From baseline to final visit (12 months)
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