A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 29
- 主要终点
- Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
研究概览
简要总结
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
详细描述
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
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
- 1 Year 至 18 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are on treatment with SKYTROFA (lonapegsomatropin)
- •Patients being clinically managed in USA
- •Patients with an appropriate written informed consent/assent as applicable for the age of the patient
排除标准
- •Patients participating in any interventional clinical study
研究组 & 干预措施
Patients on SKYTROFA Treatment
Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent
干预措施: No intervention (Other)
结局指标
主要结局
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
时间窗: 5 years
Near adult height (cm)
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
时间窗: 5 years
Incidence of Adverse Events and Serious Adverse Events
次要结局
- Assess clinical outcome assessments (COAs)(5 years)