NCT05712421已完成2 期
A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Subjects With Primary Hypothyroidism Who Are Euthyroid on Levothyroxine Replacement Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 31
- 主要终点
- The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range.
研究概览
简要总结
The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
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 for at least 6 months before Study Entry
- •On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening
- •Agree to practice a method of contraception
- •Female patients not pregnant or lactating at Screening
- •Agree to practice a method of contraception of greater than 90% reliability
- •Willing to give written informed consent for the Study
- •Provide written authorization for use and disclosure of protected health information
排除标准
- •Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star or levothyroxine
- •Hospitalization for a major illness within 4 weeks prior to Screening
- •Anticipated initiation or change in concomitant medications
- •Concomitant use of prohibited medications or supplements
- •Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.
- •For female subjects, be pregnant, nursing or planning to become pregnant during the study
研究组 & 干预措施
North Star
Experimental
干预措施: North Star (Drug)
Levothyroxine
Active Comparator
干预措施: Levothyroxine (Drug)
结局指标
主要结局
The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range.
时间窗: Week 30
次要结局
- Proportion of subjects who are euthyroid as determined by serum TSH level within the normal reference range at the end of the treatment period.(Week 30)
研究者
研究点 (31)
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