JPRN-jRCTs011180008已完成2 期
The multicenter continuous clinical study on the safety of long-term administration of bezafibrate for mitochondrial fatty acid beta-oxidation disorders - HUPE-002-03
shiraishi hideaki0 个研究点目标入组 7 人开始时间: 2019年3月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
Regarding the QOL evaluation, which is the efficacy endpoint, improvement in the patient's QOL was observed. Regarding the safety endpoint of adverse events (AE) that occurred during the study period, no problematic AE were observed, and no side effects were observed, confirming the safety of daily bezafibrate administeration. In conclusion, in terms of QOL, the efficacy and safety of bezafibrate for FAOD were confirmed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 3age old 至 <= 60age old（—）
- 性别
- All
入选标准
- •Patient who
- •1.was enrolled in the preceding study HUPE-002-02 and completed Week 78
- •2.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 ones ability to understand, and give assent with written forms if possible
排除标准
- •Patient who;
- •is considered ineligible for enrolling the study by a principal investigator or sub-investigator
研究者
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