NL-OMON52600招募中2 期
Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II - Triac Trial II
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1
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
- 0 至 11（—）
入选标准
- •1. Signed and dated informed consent form from the parents or legal guardian.
- •2. Parents stated willingness to comply with all study procedures and
- •availability for the duration
- •of the study.
- •3. The participant should be aged between 0 and 30 months on the day of
- •4. The participant should be male and have a pathogenic mutation in the MCT8
排除标准
- •1. Previous treatment with tiratricol.
- •2. Previous treatment with LT4 and/or PTU and/or other anti-thyroid medication
- •for a period longer than three months. Patients previously treated with LT4 for
- •a shorter period than 3 months may be included in the study (baseline visit)
- •six weeks (or longer) after last dose of LT4 if two consecutive analyses show
- •stable TFT*. Patients treated with PTU and/or other anti-thyroid medication for
- •a shorter period than three months may be included in the study (baseline
- •visit) six weeks (or longer) after last dose.
- •3. Major illness or recent major surgery (within four weeks of baseline visit
- •1) unrelated to MCT8
- •deficiency.
- •4. Known allergic reactions to components of the IMP. Patients with galactose
- •intolerance, Lapp lactase deficiency or malabsorption of glucose or galactose
- •(the IMP contains lactose).
- •5. Treatment with another investigational drug or participation in other
- •interventional trial within
- •three months prior to baseline visit 1.
- •*Stable TFT (T3, T4, fT4), determined as a maximal variation of 20%, should be
- •demonstrated at two separate occasions at least two weeks apart, measured on
- •the same platform.
研究者
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