EUCTR2020-001342-19-SK进行中（未招募）1 期
A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL)
Asieris MediTech Co., Ltd.0 个研究点目标入组 384 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 384
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
- •1.Biopsy-confirmed HSIL histology determined by a panel of three
- •pathologists from at the central laboratory in of each region (China, US, and Europe), biopsy tests performed before the signing of the informed consent form within 2 months prior to administration are acceptable, no repeated test is required;
- •2. Adequate colposcopy including:
- •a. visualization of entire cervical transformation zone including the squamocolumnar junction
- •b. visualization of entire lesion margin
- •3. Colposcopically visible lesion after biopsy, before treatment (Note: To ensure a colposcopically visible lesion after biopsy, the lesion should cover approximately 15% of the uterine cervix before biopsy)
- •4. Average sized uterine cervix (approximately 27 mm diameter) suitable for application of the Cevira® device
- •5. Female (not breastfeeding, with negative pregnancy test and using either a highly effective method of contraception during the entire study and 30 days after end of the study or being post-menopausal for at least 1 year or sterilized women)
- •6. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
- •7. Signed written informed consent
- •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 288
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •1.Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of the uterine cervix area
- •2.Invasive cervical cancer
- •3.Adenocarcinoma in situ, or other glandular intraepithelial lesions
- •4. Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage [ECC] test at the discretion of the investigators)
- •5. Lesion(s) extending to the vaginal vault
- •6.Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infection as per colposcopy and clinical examination
- •7.Vaginal bleeding at time of treatment at the discretion of the investigator
- •8.Pregnancy
- •10.Childbirth or miscarriage within six weeks of enrolment
- •11.Patients who previously received surgical treatment, have incomplete cervical structure and have recurrent HSIL; or patients who received other treatment after the confirmed diagnosis of HSIL
- •12.History of toxic shock syndrome
- •13.Known or suspected porphyria
- •14.Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- •15.Known allergy to silicone.
- •16.Use of heart pacemaker, and other electronic implants
- •17.Use of any mechanical barriers such as the contraceptive FemCap
- •18.Inappropriate anatomical and physiological conditions (natural or acquired through disease) such as metrorrhagia and causes (myoma, endometrial carcinoma, polyposis, etc.), uterine/cervical prolapse, vaginal dryness, period of the woman's menstruation and other. If the therapeutic drugs for concomitant diseases have the effect of treating HPV, HSIL and tumours, as well as regulating immunologic function, which will affect the efficacy evaluation of Cevira®
- •19.Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days or five half-lives of the drug, whichever is longer, prior to enrolment
- •20.Patients that in the investigator’s opinion are not suitable for participation
- •21.Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
研究者
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