jRCT2080225062已完成3 期
An open-label study of FPF1011 in patients with cerebrotendinous xanthomatosis (phase 3)
Fujimoto Pharmaceutical Corporation1 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-labeled, multicenter study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 4week old over 至 No limit（—）
- 性别
- All
入选标准
- •Main inclusion criteria.
- •The patient diagnosed with cerebrotendinous xanthomatosis.
- •Written informed consent.
- •In case of female patient of childbearing potential, the result of the pregnancy test (urine) conducted prior to registration must be negative, and she must consent to use suitable contraception not to get pregnant.
- •Outpatient.
排除标准
- •Main exclusion criteria.
- •Patient who possibly changes the dosage and administration of restricted concomitant drugs or the usage of the restricted combination therapy.
- •Patient with the serious complications in circulation, respiratory, blood, liver, kidney, digestive system, and so on.
- •Patient with allergy to commercial CDCA formulations.
- •Breastfeeding woman.
- •Patient who has received any other investigational product or post-marketing clinical trial drug within 12 weeks prior to giving informed consent.
结局指标
主要结局
-
efficacy Serum cholestanol concentrations
次要结局
- Vital signs
- Body weight
- Adverse event
- Laboratory tests
- 12-Lead electrocardiogram at rest
- MMSE-J
- Rankin Scale
- MRI
- Bone density
- The diseases or symptoms related to cerebrotendinous xanthomatosis
研究者
研究点 (1)
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