NCT06439433已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIc Clinical Trial of ALA-PDT in Patients With Cervical Intraepithelial Neoplasia Grade 2 (CIN2) in p16-positivity and High-risk HPV Infection
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.5 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2021年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 5
- 主要终点
- Response rate at week 12 after last treatment
研究概览
简要总结
Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
详细描述
A multi-center, randomized, double-blind, placebo-controlled phase IIc clinical trial of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women, 18-45 years of age
- •Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months
- •Intense desire to retain the cervical structure or function
- •High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months
- •Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
- •Signed written informed consent
排除标准
- •Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- •Invasive carcinoma possibility or lesions extending to the vaginal wall
- •Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- •Undiagnosed vaginal bleeding within the last 3 months
- •With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
- •With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years
- •Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase > 3 upper limit of normal [ULN], or total bilirubin > 1.5 ULN, or serum creatinine or blood urea nitrogen > 1.5 ULN)
- •History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months
- •Pregnancy or nursing
- •Participation in any clinical studies within the last 30 days
- •Poor compliance or inability to complete the trial
- •Subjects that the investigators judged to be not suitable to participate the study besides above
研究组 & 干预措施
ALA A Group
Experimental
ALA 500mg Group
干预措施: Aminolaevulinic acid (500-mg bottle) (Drug)
ALA B Group
Experimental
ALA 750mg Group
干预措施: Aminolaevulinic acid (750-mg bottle) (Drug)
Placebo
Placebo Comparator
Placebo Group
干预措施: Placebo (Drug)
结局指标
主要结局
Response rate at week 12 after last treatment
时间窗: Baseline and week 12 after treatments
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
次要结局
- Clearance rate of HPV at week 12 after last treatment(Baseline and week 12 after treatments)
- Response rate at week 24 after last treatment(Baseline and week 24 after treatments)
- Cure rate at week 12 after last treatment(Baseline and week 12 after treatments)
- Cure response rate at week 24 after last treatment(Baseline and week 24 after treatments)
- Clearance rate of HPV at week 24 after last treatment(Baseline and week 24 after treatments)
研究者
研究点 (5)
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