NCT03181984已完成4 期
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.7 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2017年8月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 7
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 14 to 65 years-old；
- •Clinically diagnosed of Port-wine Stain;
- •Patients receiving hemoporfin based upon the clinical judgment of the investigator;
- •Written informed consent signed and agreed to receive periodic follow-up
排除标准
- •Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
- •Scar diathesis;
- •Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application;
- •Be judged not suitable to participate the study by the investigators
研究组 & 干预措施
Hemoporfin
Experimental
干预措施: Hemoporfin (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: 96 weeks after hemoporfin application
次要结局
- Satisfaction rating of the overall treatment by investigators(8 weeks after hemoporfin application)
- Satisfaction rating of the overall treatment by subjects(8, 24 and 96 weeks after hemoporfin application)
- Response rate(8 weeks after hemoporfin application)
研究者
研究点 (7)
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