JPRN-UMIN000012934已完成2 期
The multicenter clinical trial of the efficacy and safety of bezafibrate for mitochondrial fatty acid Beta-oxidation disorders
Shimane University School of Medicine0 个研究点目标入组 10 人开始时间: 2014年1月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 3years-old 至 60years-old(—)
- 性别
- All
入选标准
- •Patient who:
- •(1) ages 3 to 60 at the time of obtaining informed consent.
- •(2) is enzymologically or genetically-proven as FAOD (any oneof CPT II, VLCAD, TFP, GA2, CPT I, MCAD, CACT) at the time of obtaining informed consent.
- •(3) weighs over 10.0kg at the time of screening test.
- •(4) has had episodes of muscular symptoms (general malaise, strong stiff shoulder or back pain, myalgia, lassitude of extremities, muscle weakness, myoglobinuria or subject-specific muscular symptoms) twice and more within 6 months or 4 times and more within 1 year prior to obtaining informed consent.
- •(5) has had the CK value which was more than double ULN at the time of attacks within 3 months prior to obtaining informed consent.
- •(6) gives written informed consent before enrolling the study.
- •The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. Subjective patients under 20-year-old should receive an adequate explanation depending on one's ability to understand, and give assent with written forms if possible.
排除标准
- •Patient who;
- •(1) has the serum creatinine level more than 1.5 mg/dL at the time of screening test
- •(2) has a heart disease or liver damage requiring treatment
- •(3) has gallstones or a previous history of them
- •(4) is treated with HMG-CoA reductase inhibitor
- •(5) takes Bezafibrate or have a history of taking it
- •(6) is pregnant or nursing women, or expected to (wishing and planning to) become pregnant
- •(7) is considered ineligible for enrolling the study by a principal investigator or subinvestigator
研究者
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