EUCTR2010-024647-32-IT进行中（未招募）不适用
Combined enzyme enhancement therapy (EET) and enzyme replacement therapy (ERT) in patients with Pompe disease - ND
IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点开始时间: 2011年5月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-The patient and / or parents / legal tutors signed informed consent -Patients of both sex younger than 65 years - The patient has a diagnosis of Pompe Disease confirmed by analysis of acid a-glucosidase enzyme activity (determined on leukocytes, muscle, or fibroblasts) and molecular analysis of the GAA gene. - The patient is on enzyme replacement therapy (ERT) for at least 6 months -Fertile female with negative BhCG -Use of contraception in fertile male patients until 3 months after the last administration of investigational drug
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- The patient has major congenital anomalies - The patient has comorbidities (excluding symptoms related to Pompe disease) involving organs and systems, which in the opinion of the investigator would preclude their inclusion in the study and potentially reduce their survival -Female patients during pregnancy -Non compliant patients
研究者
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