NCT05412979已完成2 期
A Multicenter, Randomized, Double-Blind, Crossover, Phase 2 Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Levothyroxine-to-ST-1891 dosing conversion factor
研究概览
简要总结
ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary hypothyroidism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary hypothyroidism
- •On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening
- •On a stable daily dose of levothyroxine for the 3 months prior to Screening
- •Willing to give written informed consent for the Study
排除标准
- •Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of ST-1891 or levothyroxine
- •Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening
- •Anticipated initiation or change in concomitant medications
- •Concomitant use of prohibited medications
- •Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer
研究组 & 干预措施
ST-1891
Experimental
干预措施: ST-1891 (Drug)
Levothyroxine
Active Comparator
干预措施: Levothyroxine (Drug)
结局指标
主要结局
Levothyroxine-to-ST-1891 dosing conversion factor
时间窗: Week 52
次要结局
- Time to TSH normalization(Week 52)
- Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range(Week 52)
研究者
研究点 (1)
Loading locations...
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