A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 7
- 主要终点
- Proportion of participants with histologic regression by week 17
研究概览
简要总结
This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).
详细描述
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.
Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
Secondary Objectives:
- To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3
- To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
- To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure
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
- Double (Participant, Investigator)
盲法说明
Participants, study team, and sponsor are blinded to the treatment assignment.
入排标准
- 年龄范围
- 25 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females age ≥ 25 years
- •Capable of informed consent
- •Any HPV genotype detectable by DNA test/HPV genotyping
- •Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
- •Women of childbearing potential agree to use birth control through week17 of the study.
- •Weight ≥ 50kg
排除标准
- •Pregnant and nursing women
- •Active autoimmune disease
- •Taking immunosuppressive medication
- •HIV seropositivity
- •Immunocompromised subjects
- •Evidence of concurrent cervical adenocarcinoma in situ
- •Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects
研究组 & 干预措施
Artesunate vaginal insert
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
干预措施: Artesunate vaginal insert (Drug)
Placebo vaginal inserts
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
干预措施: Placebo vaginal insert (Drug)
结局指标
主要结局
Proportion of participants with histologic regression by week 17
时间窗: 17 weeks
Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis
次要结局
- Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17(17 weeks)
- Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.(40 weeks)