Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,477
- 试验地点
- 5
- 主要终点
- Percentage of Participants With CPP Treatment
研究概览
简要总结
The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them.
There are no participants in this trial, the study only involves reviewing participants medical past and current records and collecting information.
详细描述
This is an observational, non-interventional, retrospective study to evaluate the participants characteristics, current treatment patterns and resource usage in Chinese pediatric participants diagnosed with CPP.
This study will enroll approximately 1000 participants.
The data available in an existing data source the Chinese CPP Big Data Platform database will be analyzed. All the participants will be assigned to a single observational cohort:
• Pediatric Participants With CPP
This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with CPP and treated with GnRHa from the centers participating in this study within the Chinese CPP Big Data Platform database since 2015 to
- •CPP diagnosis is based on the clinical assessment and description by CPP specialized doctors.
排除标准
- •Not received GnRHa as the treatment for CPP.
- •No available data for analysis.
结局指标
主要结局
Percentage of Participants With CPP Treatment
时间窗: Up to approximately 10 years
次要结局
- Percentage of Participants With CPP Treatment at Baseline(At Baseline)
- Percentage of Participants With Luteinizing hormone (LH) Suppression(Baseline up to approximately 10 years)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to approximately 10 years)