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).
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
\- 2 capsules per day for 20 days (week 1,2,4 \& 8)
\- 4 capsules per day for 20 days (week 1,2,4 \& 8)
\- 6 capsules per day for 8 weeks (week 1,2,4 \& 8)
Korea University Guro Hospital
Seoul, Seoul, South Korea
The Dongsan Medical Center of Keimyung University
Daegu, South Korea
Kwandong University College of Medicine Cheil Hospital
Seoul, South Korea
The Catholic University, Korea Seoul St Mary's Hospital
Seoul, South Korea
Phase 1 : Safety
Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
Time frame: up to 9 weeks
Phase 2a : Regression rate
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
Time frame: screening and 9 weeks(option), 16 weeks.
Reid Colposcopic Index
Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.
Time frame: Phase 1 : up to 9 weeks
Reid Colposcopic Index
Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
Time frame: Phase 2a : up to 16 weeks
Serum anti-E7 antibody
Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.
Time frame: 1 week, 9 weeks, 16 weeks
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Asan Medical Center
Seoul, South Korea