一项了解印度儿童生长激素缺乏症 (p GHD) 患者 Somatrogon 的研究。
对印度接受常规临床护理的 Somatrogon 参与者进行的一项多中心、非干预性前瞻性主动监测研究
The purpose of this study is to learn about the safety of Somatrogon for the treatment of pediatric growth hormone deficiency (p GHD) in India.
Pediatric GHD is a condition caused by too less amounts of growth hormone in the body. Children with GHD have a short height. GHD can be present at birth or develop later. The condition occurs if the pituitary gland makes too little growth hormone. This is a small gland at the bottom of the brain that releases hormones that affect growth and other body functions.
This study is seeking for participants who are:
- confirmed with p GHD.
- given Somatrogon to be taken as an injection.
The safety of Somatrogon injection will be checked based on side effects. These side effects can happen within 3 years after taking Somatrogon. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.
Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.
This study will help to see if Somatrogon is safe.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Pfizer CT.gov Call Center
- 电话号码：1-800-718-1021
- 邮箱：ClinicalTrials.gov_Inquiries@pfizer.com
学习地点
-
-
Karnataka
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Bengaluru、Karnataka、印度、560008
- 招聘中
- Shivajoyti Clinic
-
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Tamil Nadu
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Chennai、Tamil Nadu、印度、600006
- 招聘中
- Apollo Children's Hospital
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Coimbatore、Tamil Nadu、印度、641037
- 招聘中
- G Kuppuswamy Naidu Memorial Hospital
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Madurai、Tamil Nadu、印度、625020
- 招聘中
- Apollo Speciality Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Participants treated with Somatrogon will be followed by the treating physician as per routine clinical practice, who will collect and enter relevant participant data onto case report forms (CRFs).
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participation in any interventional clinical trials at the time of enrollment.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
小儿生长激素缺乏症患者
|
Long-acting growth hormone for pediatric growth hormone deficiency. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Somatrogon 参与者的不良事件数量
大体时间：3年
|
3年
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
报告错过注射 Somatrogon 以评估治疗依从性的参与者人数
大体时间：3年
|
3年
|
合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- C0311026
- NCT06587035 (注册表标识符：ClinicalTrials.gov)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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