Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean percent of daily recorded adherence
研究概览
简要总结
This is an Italian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
详细描述
Subjects will be enrolled in a multicenter longitudinal observational study. Parents or guardian and subjects (when applicable) will provide their Informed Consent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.
Primary Objective:
• To assess the level of adherence of subjects receiving SAIZEN® via easypod™
Secondary Objectives:
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
- To identify adherence subject profiling
- To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of >2 years
- •Under <18 years of age, or over 18 without fusion of growth plates
- •Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given
排除标准
- •Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
- •Contra-indications to SAIZEN® as defined in the Summary of Product Characteristics (SmPC)
- •Use of an investigational drug or participation in another interventional clinical study
结局指标
主要结局
Mean percent of daily recorded adherence
时间窗: At least 6 months and up to 5 years
次要结局
- Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™(At least 6 months and up to 5 years)
- Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment(At least 6 months and up to 5 years)
- Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)(At least 6 months and up to 5 years)