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)
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
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1 : Safety
Secondary Outcome
Reid Colposcopic Index
Condition
Cervical Intraepithelial Neoplasia
Intervention
BLS_ILS_E710c 500mg
Study Arms / Comparison Groups
BLS_ILB_E710c 500mg
Description: Drug: BLS_ILB_E710c 500mg Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
19
Start Date
March 2014
Completion Date
April 2016
Primary Completion Date
March 2016
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender
Female
Ages
20 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Jae-Kwan Lee, MD, PhD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02195089
Organization ID
UMT2013-BLS-ILB-E710c
Secondary IDs
12591
Responsible Party
Sponsor
Study Sponsor
BioLeaders Corporation
Study Sponsor
Jae-Kwan Lee, MD, PhD, Principal Investigator, Korea University Guro Hospital
Verification Date
April 2016