NCT07747103招募中3 期
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 466
- 试验地点
- 25
- 主要终点
- Thyroid-stimulating hormone (TSH) levels within the normal reference range at 24 weeks and at a prior post-baseline visit with no intervening out of range values
研究概览
简要总结
The North Star study is a multi-center, Phase 3, open-label, single-arm clinical study to evaluate the Efficacy and Safety of North Star therapy.
详细描述
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening
- •Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT
- •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
- •Hospitalization for a major illness within 5 weeks prior to Screening
- •Concomitant use of prohibited medications or supplements
- •Have uncontrolled diabetes
- •Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening
- •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
North Star Desiccated Porcine Thyroid Extract Tablets
干预措施: Desiccated Porcine Thyroid Extract Tablets (Drug)
结局指标
主要结局
Thyroid-stimulating hormone (TSH) levels within the normal reference range at 24 weeks and at a prior post-baseline visit with no intervening out of range values
时间窗: 24 weeks
次要结局
- Collection and review of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions, adverse events of special interest, clinical laboratory evaluations, 12-lead ECG, and physical examination.(30 weeks)
研究者
研究点 (25)
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