EUCTR2017-001031-39-FR进行中（未招募）1 期
BABH Study: Efficacy and safety of bevacizumab on severe bleedings associated with Hemorrhagic Hereditary Telangiectasia (HHT). A National, randomized multicenter phase III study. - BABH
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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 = 18 years.
- •- Patients who have given their free informed and signed consent.
- •- Patients affiliated to a social security scheme or similar.
- •- Patients monitored for clinically confirmed HHT (presence of at least three Curaçao criteria) and / or with molecular biology confirmation.
- •- Blood transfusions with the requirement for at least 3 units of blood in the 3-month period before study enrollment, related to epistaxis or digestive bleeding.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Pregnant or nursing (lactating) women or likely to become so in the course of the study.
- •- Patients who are protected adults under the terms of the law (French Public Health Code).
- •- Refusal to consent.
- •- Patients for whom the diagnosis of HHT has not been confirmed clinically and / or by molecular biology study.
- •- Active infection and/or fever>38°C
- •- Participation in another clinical trial within 28 days prior to inclusion.
- •- Hypersensitivity to the active substance or to any of the excipients.
- •- Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other recombinant human or humanized antibodies.
- •- Patients who have taken Avastin ® intravenously in the 6 months prior to inclusion.
- •- Patients who have had a therapeutic endoscopy for gastrointestinal bleeding or ENT surgery for epistaxis will have to wait at least 3 months less after treatment to be included if bleeding persists.
- •- Patients who had a surgery in the month prior inclusion or planned surgery within 6 months
- •- Severe peripheral arterial disease with ulcerations
- •- Unhealed wound
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