临床试验/NCT04966416

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: 2023年5月25日

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.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

发起方

Szeged University

申办方类型

Other

责任方

Principal Investigator

主要研究者

László Kovács MD, PhD

Professor

Szeged University

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