NCT05775523招募中不适用
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 29
- 主要终点
- Occurrence of neoplasms (benign, malignant and unspecified)
研究概览
简要总结
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
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）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patients with GHD who are on treatment with lonapegsomatropin
- •Patients being clinically managed in Europe or the USA
- •Appropriate written informed consent/assent as applicable for the age of the patient
- •Patients willing to comply with follow-up requirements of the study
排除标准
- •Patients participating in any interventional clinical trial for short stature
- •Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
- •Patients for whom treatment with lonapegsomatropin is contraindicated
- •Patients with closed epiphyses
- •Patients with active malignant tumours
- •Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
- •Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin
研究组 & 干预措施
Patients on SKYTROFA (Lonapegsomatropin)Treatment
SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection
干预措施: No intervention (Drug)
结局指标
主要结局
Occurrence of neoplasms (benign, malignant and unspecified)
时间窗: 5 years
Occurrence of type 2 diabetes mellitus
时间窗: 5 years
次要结局
- Occurrence of renal, hepatic, immunologic and neurologic adverse events(5 years)
- Occurrence of medication errors in patients treated with lonapegsomatropin(5 years)
- Compare the occurrence of neoplasms (benign, malignant and unspecified) in patients treated with lonapegsomatropin with historical data from literature(5 years)
- Compare the occurrence of type 2 diabetes mellitus in patients treated with lonapegsomatropin with historical data from literature(5 years)
- Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy(5 years)
研究者
研究点 (29)
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