A multicenter, non-interventional prospective active surveillance study among patients receiving Somatrogon under routine clinical care in India
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- To estimate incidence rates (IRs) of safety events of interest among participants on Somatrogon.
研究概览
简要总结
This is a multi-centre, non-interventional, prospective active surveillance study of participants exposed to Somatrogon, as prescribed by the treating physician in routine realworld clinical practices in India. Participant treatment with a particular therapeutic regimen will be determined at the discretion of the treating physician under routine clinical care. This study involves primary data collection with investigators and sites.
Primary Objectives: To estimate IRs of safety events of interest among participants on Somatrogon.
Secondary Objectives: To evaluate treatment adherence and compliance of Somatrogon.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Prescription of Somatrogon for p GHD in participants aged 3 years or more.
- •Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study.
- •Assent will also be sought from children of applicable age in line with national guidance.
- •In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care.
排除标准
- •Participation in any interventional clinical trials at the time of enrollment.
结局指标
主要结局
To estimate incidence rates (IRs) of safety events of interest among participants on Somatrogon.
时间窗: Data will be collected at baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
次要结局
- To evaluate treatment adherence(and compliance of Somatrogon)
研究者
Dr Mukundraj Keny
Pfizer Products India Private Limited