Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
NCT ID: NCT02195089
Last Updated: 2016-04-19
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2014-03-31
2016-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BLS_ILB_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 500mg
\- 2 capsules per day for 20 days (week 1,2,4 \& 8)
BLS_ILS_E710c 1000mg
* Drug: BLS\_ILS\_E710c 1000mg
* Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)
BLS_ILB_710c 1000mg
\- 4 capsules per day for 20 days (week 1,2,4 \& 8)
BLS_ILS_E710c 1500mg
* Drug: BLS\_ILS\_E710c 1500mg
* Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)
BLS_ILS_E710c 1500mg
\- 6 capsules per day for 8 weeks (week 1,2,4 \& 8)
Interventions
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BLS_ILS_E710c 500mg
\- 2 capsules per day for 20 days (week 1,2,4 \& 8)
BLS_ILB_710c 1000mg
\- 4 capsules per day for 20 days (week 1,2,4 \& 8)
BLS_ILS_E710c 1500mg
\- 6 capsules per day for 8 weeks (week 1,2,4 \& 8)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
50 Years
FEMALE
No
Sponsors
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BioLeaders Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jae-Kwan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Tae Jin Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kwandong University College of Medicine Cheil Hospital
Jong Sup Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University, Korea Seoul St Mary's Hospital
Chi-Heum Cho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Dongsan Medical Center of Keimyung University
Jong Hyeok Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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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
Asan Medical Center
Seoul, , South Korea
Countries
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References
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Park YC, Ouh YT, Sung MH, Park HG, Kim TJ, Cho CH, Park JS, Lee JK. A phase 1/2a, dose-escalation, safety and preliminary efficacy study of oral therapeutic vaccine in subjects with cervical intraepithelial neoplasia 3. J Gynecol Oncol. 2019 Nov;30(6):e88. doi: 10.3802/jgo.2019.30.e88.
Other Identifiers
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12591
Identifier Type: OTHER
Identifier Source: secondary_id
UMT2013-BLS-ILB-E710c
Identifier Type: -
Identifier Source: org_study_id
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