EUCTR2018-001978-22-FR进行中（未招募）1 期
Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. - ITS Pilot
CHU de LIMOGES0 个研究点目标入组 40 人开始时间: 2018年9月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patient presenting with:
- •? ectopic calcification secondary to dermatomyositis or ? ectopic calcification secondary to systemic sclerosis And aged 18 years old or higher
- •? ectopic ossification secondary to iPPSD2
- •And aged = 2 years old and = 17 years old
- •And after the specific authorization of ANSM and CPP
- •- Indication of STS injection validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification
- •- Patient with no planned surgery of the calcifications/ossifications for the twelve coming months
- •-Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence). Contraception will be extended up to one month after the last injection.
- •- Informed consent signed by the patient / parents
- •- Patient affiliated to (or beneficiary of) the social security system
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Allergy to STS, sulfites or one of the excipients used
- •- Contraindication to local injection of STS
- •- Anticoagulant therapy
- •- Pregnant, parturient or breastfeeding woman
- •- Patient deprived of freedom by a court judgment or an administrative decision
- •- Patient undergoing psychiatric care under coercion
- •- Legally protected adult patients (guardianship / curatorship)
- •- Patient unable to give consent
- •- Patient placed under judicial protection
研究者
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