Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd). An Observational, Prospective, Multicentre, Cohort Study on Italian Patients With Haemophilia A in Prophylaxis Treatment With Turoctocog Alfa Under Current Clinical Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female, age above or equal to 12 years at the time of signing informed consent.
- •Haemophilia A (any severity), needing prophylactic therapy (with the usual recommended doses).
- •Decision to treat with turoctocog alfa, made by the treating Physician and the subject/Legally Acceptable Representative (LAR) based on local label before and independently from the decision to include the subject in this study.
排除标准
- •Previous participation in this study, defined as previously signed informed consent;
- •Presence of other coagulation disorders;
- •Presence of any inhibitor;
- •Mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.
研究组 & 干预措施
Haemophilia A
Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.
干预措施: Turoctocog alfa (Drug)
结局指标
主要结局
Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)
时间窗: Baseline (week 0)
Count
次要结局
- Reported reasons for change of PPX regimens(Final visit (12 months))
- Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW(Final visit (12 months))
- Change of PPX regimen: YES/NO(12 months after treatment initiation)
- Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire(Final visit (12 months) vs Baseline (week 0))
- Difference in circulating turoctocog alfa levels(Final visit (12 months) vs Baseline (week 0))
- Individual Annual Bleeding Rate (ABR)(From baseline to final visit (12 months))