NL-OMON41314已完成2 期
A phase II, open-label, extension study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy - PRO044-CLIN-02
Prosensa Therapeutics B.V.0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •1. Subjects previously treated with PRO044 in the PRO044-CLIN-01 study.;2. Continued use of glucocorticoids for a minimum of 60 days prior to study entry
- •with a reasonable expectation that the subject will remain on steroids for the
- •duration of the study. Changes to or cessation of glucocorticoids will be at the
- •discretion of the PI in consultation with the subject/parent and the Medical
- •Monitor. If the subject is not on steroids, involvement in the study needs to be
- •discussed with the medical monitor.
排除标准
- •1. Current or history of liver or renal disease.
- •2. Acute illness within 4 weeks prior to the first dose of PRO044 (Week 1) which may interfere with the measurements.
- •3. Severe cardiac myopathy which in the opinion of the Investigator prohibits participation in this study.
- •4. Need for daytime mechanical ventilation.
- •5. Screening aPTT above the upper limit of normal (ULN).
- •6. Screening platelet count below the lower limit of normal (LLN).
- •7. Use of anticoagulants, antithrombotics or antiplatelet agents.
- •8. Use of any investigational product within 6 months prior to the start of Screening for the study or during participation in the study.
- •9. Current or history of drug and/or alcohol abuse.
研究者
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