A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining the Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for the Treatment of Adults With Primary Hypothyroidism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,800
- 试验地点
- 275
- 主要终点
- Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response
研究概览
简要总结
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid 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
- Triple (Participant, Care Provider, Investigator)
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
- •Have a diagnosis of primary hypothyroidism made >= 12 months prior to Screening.
- •Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit.
- •Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion.
- •Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.
排除标准
- •Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T
- •History of alcohol or other substance abuse within the previous 6 months prior to the Screening.
- •Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.
研究组 & 干预措施
Group 1
Participants will receive Armour Thyroid for up to 81 weeks.
干预措施: Armour Thyroid (Drug)
Group 2
Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
干预措施: Armour Thyroid (Drug)
Group 2
Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
干预措施: Levothyroxine (Drug)
结局指标
主要结局
Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response
时间窗: Week 55
TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L (inclusive). TSH response will be determined at Week 55 and at a prior visit with no out-of-range TSH values in between (response rate is tested against a specified non-inferiority margin).
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 90 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period(Week 55)
- Percentage of Participants who Achieve TSH Response(Week 55)
- Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid(Up to approximately 29 weeks)