NCT06202027招募中不适用
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)
研究概览
简要总结
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of CRYSVITA injection 10, 20, and 30mg, equivalent to in routine clinical settings
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
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
- •Those (or his/her legal guardian) who have agreed in writing to participate in the survey. Children who have obtained a written consent of his/her legal guardian about participation in this survey. In case of pediatric patient, explain sufficiently what you think the patient can understand. In this case, the legal guardian may provide supplementary explanations of the survey.
排除标准
- •Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
- •Patients who intend to use this drug for other purposes
- •Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
- •Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)
结局指标
主要结局
safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)
时间窗: 4 weeks after follow up
Investigators have to record all events (i.e., all AEs and special situations) in CRFs including undesirable medical findings obtained during the medical examination as well as spontaneous reports from subjects. All AEs occurring for at least 4 weeks after the last dose of CRYSVITA® should be included in this study
次要结局
- Serum Phosphorus Concentration(24 weeks)
- 1,25-Dihydroxyvitamin D(24 weeks)
研究者
研究点 (10)
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