NCT04484415Unknown3 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 (Hong Kong) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2020年11月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- The proportion of responders at 6 months after first treatment
研究概览
简要总结
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).
详细描述
To evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.A total of 384 subjects will be enrolled globally, among which, 300 subjects of them will be enrolled in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from a central laboratory in each region (China, US, and Europe);
- •Adequate colposcopy including:
- •visualization of entire cervical transformation zone including the squamocolumnar junction
- •visualization of entire lesion margin
- •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)
- •Average sized uterine cervix suitable for application of the Cevira® device
- •Use of adequate birth control until completion of the 6 month assessment visit
- •Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
- •Signed written informed consent
排除标准
- •Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of the uterine cervix area
- •Invasive cervical cancer
- •Adenocarcinoma in situ, or other glandular intraepithelial lesions
- •Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage [ECC] test at the discretion of the investigators)
- •Lesion(s) extending to the vaginal vault
- •Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infection as per colposcopy and clinical examination
- •Vaginal bleeding at time of treatment at the discretion of the investigator
- •Childbirth or miscarriage within six weeks of enrolment
- •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
- •History of toxic shock syndrome
- •Known or suspected porphyria
- •Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- •Known allergy to silicone
- •Use of heart pacemaker
- •Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days
- •Patients that in the investigator's opinion are not suitable for participation
- •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
结局指标
主要结局
The proportion of responders at 6 months after first treatment
时间窗: 6 months
A responder is defined as follows: * Normal histology; or * LSIL histology and clearance of baseline HPV
次要结局
- The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.(6 months)
- The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.(6 months)
- The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.(6 months)
- The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.(6 months)
研究者
研究点 (1)
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相关资讯
EMA Accepts Marketing Authorization Application for Cevira, First-in-Class Photodynamic Therapy for Cervical Lesions- The European Medicines Agency has accepted Asieris Pharmaceuticals' marketing authorization application for Cevira (APL-1702), a first-in-class photodynamic therapy for treating high-grade squamous intraepithelial lesions.
- Cevira represents a paradigm shift as a drug-device combination integrating hexaminolevulinate hydrochloride ointment with a disposable cervical light applicator for non-surgical treatment.
- The application is supported by results from an international multicenter Phase III clinical trial that enrolled over 20% European patients and achieved its primary endpoint in September 2023.6 months agoAsieris Pharmaceuticals' Cevira (APL-1702) Shows Promise in HSIL Treatment: Phase III Subgroup Analysis- Asieris Pharmaceuticals presented Phase III trial subgroup analysis of Cevira (APL-1702) at the 2024 CSCO Annual Meeting, focusing on age-related efficacy in treating cervical HSIL.
- The study demonstrated a 15-20% increase in pathological regression rate in the 20-40 age group treated with APL-1702 compared to placebo at six months.
- APL-1702 showed enhanced HPV clearance rates in the 20-30 age group, indicating its potential to facilitate regression from HSIL to LSIL and clear high-risk HPV infections.
- The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024.last year