Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- Drug: BLS_ILS_E710c 500mgDrug: BLS_ILB_710c 1000mgDrug: BLS_ILS_E710c 1500mg
- Registration Number
- NCT02195089
- Lead Sponsor
- BioLeaders Corporation
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 19
- Pre-menopausal patients between age of 20 and 50.
- Patients with cervical intraepithelial neoplasia 3(CIN3).
- Only infection with HPV type 16.
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BLS_ILB_E710c 500mg BLS_ILS_E710c 500mg * Drug: BLS_ILB_E710c 500mg * Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8) BLS_ILS_E710c 1000mg BLS_ILB_710c 1000mg * Drug: BLS_ILS_E710c 1000mg * Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8) BLS_ILS_E710c 1500mg BLS_ILS_E710c 1500mg * Drug: BLS_ILS_E710c 1500mg * Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)
- Primary Outcome Measures
Name Time Method Phase 2a : Regression rate 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 up to 9 weeks Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
- Secondary Outcome Measures
Name Time Method Reid Colposcopic Index Phase 2a : up to 16 weeks Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
Serum anti-E7 antibody 1 week, 9 weeks, 16 weeks Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.
Trial Locations
- Locations (5)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Dongsan Medical Center of Keimyung University
🇰🇷Daegu, Korea, Republic of
The Catholic University, Korea Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kwandong University College of Medicine Cheil Hospital
🇰🇷Seoul, Korea, Republic of