EUCTR2017-004625-32-GB进行中（未招募）1 期
ong-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- 性别
- Male
入选标准
- •1. Completed a clinical trial evaluating casimersen or golodirsen, per protocol.
- •2. If sexually active, agrees to use a male condom during such activity for the entire duration of the study and for 90 days after the last dose of study drug. The sexual partner must also use a medically acceptable form of contraceptive (eg, female oral contraceptives) during this time frame.
- •3. Is able to understand and comply with all the study requirements and, if under 18 years of age, has (a) parent(s) or legal guardian(s) who is (are) able to understand and comply with all the study requirements.
- •4. Is willing and legally able to provide written informed assent and/or consent, or, if not legally able to provide written informed assent and/or consent, has (a) parent(s) or legal guardian(s) who is (are) willing and legally able to provide written informed assent and/or consent for the patient to participate in the study.
- •5. Is between 7 and 23 years of age, inclusive, at enrollment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 260
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any medical condition that could, in the Investigator's opinion: adversely affect the safety of the patient, make it unlikely that the course of treatment would be completed, or impair the assessment of study results.
- •2. Any patient who, in the Investigator's opinion, seems unable/unwilling to comply with the study procedures.
- •3. Treatment with any investigational therapies at the time of consent or within 6 months prior to dosing if there was an unexpected gap in treatment.
研究者
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