NCT03206138Unknown不适用
A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
研究概览
简要总结
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
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
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able and willing to comply with all study procedures and voluntarily signs informed consent form.
- •Female subjects age 19-50 years.
- •HPV 16 and/or 18 positive.
- •Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area
- •Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.
排除标准
- •Pregnancy or breastfeeding
- •History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
- •Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- •Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.
结局指标
主要结局
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
时间窗: at week 20
次要结局
- The change of cytology of uterine cervix compared to baseline.(at screening, week 12, week 20, and week 36)
- Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.(at week 20, and week 36)
- Flt-3L concentrations in blood samples.(at week 14, week 20, and week 36.)
研究者
Jongsup Park
Professor
Seoul St. Mary's Hospital
研究点 (2)
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