jRCT2031220210已完成不适用
A phase III, open label study of FPF3401 in patients with hyposelenemia
Fujimoto Pharmaceutical Corporation0 个研究点目标入组 53 人开始时间: 2022年7月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 主要终点
- serum selenium concentrations
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 6month old over 至 No limit（—）
- 性别
- All
入选标准
- •Previously untreated patients
- •Patients with hyposelenemia or suspected hyposelenemia.
- •Patients having capability of intestinal absorption of selenium.
- •Patients on enteral nutrition therapy or diet therapy.
- •Patients with serum selenium concentrations below the reference value.
- •High-dose treatment patients
- •Patients with hyposelenemia or suspected hyposelenemia.
- •Patients daily treated with high-dose selenium preparations by oral or tube administration.
- •Patients having capability of intestinal absorption of selenium.
排除标准
- •Previously untreated patients
- •Patients mainly treated with their nutrition intravenously.
- •Patients treated with any of the following drugs.
- •(1)Selenium preparations
- •(2)Teduglutide
- •Patients allergic to selenium.
- •High-dose treatment patients
- •Patients treated with any of the following drugs.
- •(1)Selenium preparations (except for oral or tube administration)
- •(2)Teduglutide
- •Patients allergic to selenium.
结局指标
主要结局
serum selenium concentrations
A rate of cases with serum selenium concentrations reaching and being maintained at the reference interval
次要结局
未报告次要终点
研究者
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