KCT0000733招募中未知
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(CIN I)
Bioleaders0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 40(Year)（—）
- 性别
- Female
入选标准
- •1.Fertile women between age of 20 and 40
- •2.Patients with cervical intraepithelial neoplasia 1(CIN1)
- •3.HPV(Human Papilloma Virus) positive(+)
- •4.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
- •5.AST(Aspartate Aminotransferase) no less than 4 times higher than
- •normal ALT(Alanine Aminotransferase) no less than 4 times higher than
- •6.Normal for EKG(Electrocardiography) and no active disease detected
- •trough chest X-ray
- •7.Be informed of the nature of the study and will give written informed consent
排除标准
- •1.Malignant tumor in any organ other than cervical intraepithelial
- •2.Active liver disease, immune disorder and severe renal failure
- •3.Leukemia, collagenosis, sclerosis, autoimmune disease, clinically
- •significant allergic disease(mild allergic symptom not required
- •medicine excluded)
- •4.Diagnosed diabetes
- •5.Taking any of followings affecting immunological reaction within 7
- •days (Glucocorticoid, vitamins, health food and oriental medicine etc)
- •6.History of HPV(Human Papilloma Virus) vaccination
- •7.Pregnancy and breastfeeding
- •8.Registered in other clinical trials
- •9.Patients whom the investigator considers inappropriate to participate
- •in the study
研究者
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