A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Phase 2a : Regression rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).
详细描述
This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.
The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal patients between age of 20 and
- •Patients with cervical intraepithelial neoplasia 3(CIN3).
- •Only infection with HPV type
- •Patients with Capable of observation of all of lesions by Colposcopy biopsy.
- •Be informed of the nature of the study and will give written informed consent.
- •Be agree with contraception during study
- •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 /mm^3
- •Normal for EKG(Electrocardiography)
- •AST/ALT : 2.5 times less than normal range
排除标准
- •Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.
- •Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.
- •Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)
- •Investigational product within three months before the start of the drug administration to patients treated with other test drug.
- •Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.
- •Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.
- •Pregnant or lactating women
- •Patient with HBV or HCV infection (except for Asymptomatic)
- •Patient that Investigator judge
- •Deemed inappropriate for researchers to judge the patient
研究组 & 干预措施
BLS_ILB_E710c 500mg
- Drug: BLS_ILB_E710c 500mg
- Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8)
干预措施: BLS_ILS_E710c 500mg (Drug)
BLS_ILS_E710c 1000mg
- Drug: BLS_ILS_E710c 1000mg
- Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 & 8)
干预措施: BLS_ILB_710c 1000mg (Drug)
BLS_ILS_E710c 1500mg
- Drug: BLS_ILS_E710c 1500mg
- Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 & 8)
干预措施: BLS_ILS_E710c 1500mg (Drug)
结局指标
主要结局
Phase 2a : Regression rate
时间窗: screening and 9 weeks(option), 16 weeks.
Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal
Phase 1 : Safety
时间窗: up to 9 weeks
Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
次要结局
- Reid Colposcopic Index(Phase 2a : up to 16 weeks)
- Serum anti-E7 antibody(1 week, 9 weeks, 16 weeks)