Post Marketing Surveillance (PMS) Study for Ngenla Prefilled Pen in Pediatric Patients Who Have Endogenous Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone in Korea
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
- 565
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in Korea.
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
- 3 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product;
- •2. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
排除标准
- •Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products;
- •Patients who have contraindications to somatrogon as specified in the approved LPD.
- •Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product
研究组 & 干预措施
Participants receiving Ngenla
Participants receiving Ngenla according to label
干预措施: Ngenla (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: up to 28 days after last dose
次要结局
- Change from baseline in Annualized Height Velocity in cm/year(baseline, up to 12 months)
- Change from baseline in Bone Maturation (BM)(baseline, up to 12 months)
- Change from baseline in Height Standard Deviation Score(baseline, up to 12 months)