A Multi-center, Randomized, Double Blind, Placebo Control, Parallel Design, Phase 2a Trial to Evaluate the Efficacy and Safety of PGA (Poly-gamma Glutamic Acid) for the Fertile Women With Cervical Intraepithelial Neoplasia 1 (CIN1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Regression rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).
详细描述
This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1) between the treatment group and the control group.
The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation.
The control group will be observed for 12 weeks without any comparator.
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
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fertile women between age of 20 and 49
- •Patients with cervical intraepithelial neoplasia 1(CIN1)
- •HPV(Human Papilloma Virus) positive(+)
- •White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L
- •AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal
- •Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray
- •Be informed of the nature of the study and will give written informed consent
排除标准
- •Malignant tumor in any organ other than cervical intraepithelial neoplasia
- •Active liver disease, immune disorder and severe renal failure
- •Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)
- •Diagnosed diabetes
- •Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)
- •Pregnancy and breastfeeding
- •Registered in other clinical trials
- •Patients whom the investigator considers inappropriate to participate in the study
研究组 & 干预措施
Poly-gamma Glutamic Acid
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.
干预措施: Poly-gamma Glutamic Acid (Drug)
Placebo
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Regression rate
时间窗: up to 12 weeks
Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.
次要结局
- Pap smear test(up to 12 weeks)
- HPV (Human Papilloma Virus) DNA Test(up to 12 weeks)
- HPV (Human Papilloma Virus) Hybrid CaptureII Test(up to 12 weeks)
- Reid Colposcopic Index(up to 12 weeks)
- NK (Natural Killer) Cell Activity(up to 12 weeks)
- Peripheral Blood Mononuclear Cells (PBMCs)Test(up to 12 weeks)