EUCTR2018-004072-35-FR进行中（未招募）1 期
Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO
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
- CHU de Nice
- 入组人数
- 8
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
- All
入选标准
- •Age > 50 years old
- •Decreased visual acuity (BVA), regardless of degree of severity, sudden onset in the context of newly diagnosed or suspected Horton's disease
- •Diagnostic BAV <58 days
- •Conventional treatment of Horton's disease: Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of the referring physician for his vascularity and + - immunosuppressive or biologic pathology if necessary.
- •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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •BAV and ischemia over 5 days
- •Underlying hepatocellular insufficiency known
- •Patient under guardianship or curatorship
- •Hypersensitivity to the active substance or to any of the excipients
- •Moderate to severe hepatic insufficiency corresponding to class B or C of the Child-Pugh classification
- •Serum levels of hepatic aminotransferases, aspartate aminotransferases (ASTs) and / or alanine aminotransferases (ALATs), greater than 3 times the upper limit of normal before start of treatment
- •Patient on cyclosporine A therapy
研究者
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