Subcutaneous Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. - I17004

Centre Hospitalier Et Universitaire De Limoges0 个研究点目标入组 40 人开始时间: 2024年2月19日最近更新: 2024年7月22日

适应症

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•Patient presenting with ectopic calcification secondary to dermatomyositis or ectopic calcification secondary to systemic sclerosis And aged 18 years old or higher or ectopic ossification secondary to iPPSD2 And aged = 2 years old and = 30 years old, Indication of STS infusion 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. Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection, Informed consent signed by the patient / parents, Patient affiliated to (or beneficiary of) the social security system

•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), Adult patient unable to give consent, Patient placed under judicial protection

发起方

Centre Hospitalier Et Universitaire De Limoges