EUCTR2015-002379-81-GB进行中（未招募）1 期
International, multi-center, open-label FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pharnext SA
- 入组人数
- 187
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
- All
入选标准
- •Patients under P and D1 must have completed 15 months of double-blind treatment in the primary study CLN-PXT3003-02, including all procedures required at the Study Termination visit (V6) or patients under D2 prematurely discontinued from CLN-PXT3003-02 (due to sponsor decision on September 18th, 2017) must have performed an early V6
- •Patients who completed the V6 assessments within 4 weeks prior to extension study or patients who have completed a new baseline visit (VB) if the V6 assessments were not completed in the 4 weeks prior to study entry.
- •Female patients must agree to continue using an approved method of birth control throughout the extension study.
- •Patients must sign a written informed consent, specific to the extension study, in order to participate in this study. For minor patients, both patient’s and parents’ consent shall be collected.
- •Patients must sign a written informed consent to continue after V9 to access to study treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients with any of the following criteria will be excluded from entry:
- •1. Presenting any clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
- •2. Any unauthorized concomitant treatments, in the 4 weeks preceding study entry, as study CLN-PXT3003-02.
研究者
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