Spots Global Cancer Trial Database for Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
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Trial Identification
Brief Title: Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Official Title: 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)
Study ID: NCT02195089
Conditions
Study Description
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
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The Dongsan Medical Center of Keimyung University, Daegu, , Korea, Republic of
Kwandong University College of Medicine Cheil Hospital, Seoul, , Korea, Republic of
The Catholic University, Korea Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Jae-Kwan Lee, MD, PhD
Affiliation: Korea University Guro Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Tae Jin Kim, MD, PhD
Affiliation: Kwandong University College of Medicine Cheil Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jong Sup Park, MD, PhD
Affiliation: The Catholic University, Korea Seoul St Mary's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Chi-Heum Cho, MD, PhD
Affiliation: The Dongsan Medical Center of Keimyung University
Role: PRINCIPAL_INVESTIGATOR
Name: Jong Hyeok Kim, MD, PhD
Affiliation: Asan Medical Center
Role: PRINCIPAL_INVESTIGATOR
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