EUCTR2014-005679-96-DE进行中（未招募）1 期
An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa
Scioderm, INC, An Amicus Therapeutics Company0 个研究点目标入组 152 人开始时间: 2015年3月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Informed Consent form signed by the patient or patient's legal
- •representative; if the patient is under the age of 18 but
- •capable of providing assent, signed assent from the patient.
- •2. Patient (or caretaker) must be willing to comply with all protocol
- •requirements.
- •3. Patient who completed the SD-005 study (on study drug at Visit 5)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who do not meet the entry criteria outlined in the Inclusion criteria.
- •2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-005 for female patients of childbearing potential and repeated at Visit 1 if these visits do not occur on the same day)
- •3. Females of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.
研究者
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