NCT04966416尚未招募不适用
The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis
Szeged University0 个研究点目标入组 60 人开始时间: 2023年8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
- 60
- 主要终点
- Change in the size of calcinosis nodues.
研究概览
简要总结
Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.
详细描述
Calcinosis, the formation of hydroxyapatite subcutaneous nodules, often complicates systemic sclerosis. There is no standard treatment for it. Based upon our preclinical experienc, we would like to test it orally administered pyrophosphate inhibits calciosis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to meet ACR/ EULAR classification criteria
排除标准
- •severe upper minfestation of SSC
- •hypo- or hyperthyreoidism
- •QT prolongation on ECG
结局指标
主要结局
Change in the size of calcinosis nodues.
时间窗: 52 weeks+ 16 weeks
Volumetric assessment with low energy CT
次要结局
- Change of the size of calcinosis by ultrasound(52 weeks+ 16 weeks)
- Change of the severity of sympthoms caused by calcinosis(52 weeks+ 16 weeks)
- Change of the activity of calcinosis(52 weeks+ 16 weeks)
研究者
László Kovács MD, PhD
Professor
Szeged University
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