Ngenla® Subcutaneous Injection Special Investigation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of Glucose metabolism disorders per exposure period
研究概览
简要总结
The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.
Registration criteria of this study are the patients who:
- Have GHD without epiphyseal closure and receiving Ngenla for the first time.
- Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
详细描述
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.
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
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NGENLA (Somatrogon)
Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)
干预措施: NGENLA (Somatrogon) (Drug)
结局指标
主要结局
Incidence of Glucose metabolism disorders per exposure period
时间窗: up to 5 years
Growth rate standard deviation score (SDS) for chronological age
时间窗: up to 5 years
The number of patients reporting Adverse Events (AEs)
时间窗: up to 5 years
Incidence of Neoplasm per exposure period
时间窗: up to 5 years
Change in height SDS for chronological age and time-course of height SDS for chronological age
时间窗: up to 5 years
Proportion of reported Adverse Events
时间窗: up to 5 years
Annual growth rate (cm/year)
时间窗: up to 5 years
次要结局
未报告次要终点