NCT06327828尚未招募不适用
Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care
Medical University of Graz2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices
研究概览
简要总结
The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Graves' hyperthyroidism [Thyroid-stimulating hormone <0.1 mU/L, elevated free thyroxine levels (fT4) above the upper limit of normal and positive Thyrotropin receptor antibody (TRAb) according to local laboratory results], measured within the last month prior to the inclusion date
- •Patients not yet receiving antithyroid treatment, or having received antithyroid treatment continuously for less than 4 weeks, or relapse or recurrence of Graves' hyperthyroidism defined as patients previously having received and discontinued treatment with antithyroid drugs for at least 4 weeks)
- •Age 18 years or older
- •Provision of written informed consent
排除标准
- •Previous treatment with radioactive iodine
- •Ongoing antithyroid treatment for more than one month
- •Pregnancy
- •Treatment with propylthiouracil
结局指标
主要结局
The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices
时间窗: 18 months
The performance index is the deviation from the desired free thyroxine (fT4) value
次要结局
- Comparison in terms of cumulative methimazole dosing(18 months)
- Comparison based on free thyroxine (fT4) target range(18 months)
研究者
研究点 (2)
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