EUCTR2017-004866-86-FR进行中（未招募）1 期
Evaluation of the benefit of adjuvant treatment with hydroxychloroquine to usual medical care for uncomplicated term pregnancy in patients with primary obstetrical antiphospholipid syndrome: randomized, double-blind, placebo-controlled phase II study. HYDROSAPL study - HYDROSAP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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
- 性别
- Female
入选标准
- •- Woman aged = to 18 years
- •- Obstetric SAPL (modified Sapporo criteria = Sydney criteria) defined as fetal death =10 weeks of amenorrhea without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity <34SA related to placental insufficiency with or without thrombotic SAPL
- •- Spontaneous pregnancy in progress before 14 SA
- •- Ability to give informed, written, dated and signed consent prior to the commencement of any trial-related procedure and to comply with protocol recommendations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Other SAPL subgroups: early isolated miscarriage <10 SA
- •- Minor patient
- •- Not affiliated to a social security scheme
- •- Contraindication to hydroxychloroquine
- •o retinopathies,
- •o hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication, including lactose
- •- Systemic systemic lupus, associated Sjogren syndrome
- •- Hydroxychloroquine treatment in progress
- •- Patient under guardianship or curatorship
- •- Patient deprived of liberty
研究者
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