EUCTR2013-003107-19-GB进行中（未招募）1 期
Phase II clinical trial investigating the use of epigallocatechin-3-gallate (Veregen) in the treatment of vulval intraepithelial neoplasia - EPIVIN trial (v 1.0)
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
- 26
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
- •= 18 years of age, histological confirmation of usual-type vulval intraepithelial neoplasia (VIN3)*, at least one lesion that can be accurately measured (using the RECIST 1.1 criteria) in at least one dimension with longest diameter = 20 mm, using a reliable method of contraception (excluding condoms), written informed consent to participate in the trial.
- •*All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology; 10% of biopsies will be independently reviewed by a second pathologist
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease; pregnant, breast feeding or trying to conceive; treated for VIN within the previous four weeks; known allergy to Veregen or any of its components; patients suffering from immunosuppressive disorder or taking immunosuppressives; unable to comply with the protocol.
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