Cervical Intraepithelial Neoplasia
Conditions
Keywords
Treatment of 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
Interventions
DRUGBLS_ILS_E710c 500mg
\- 2 capsules per day for 20 days (week 1,2,4 & 8)
DRUGBLS_ILB_710c 1000mg
\- 4 capsules per day for 20 days (week 1,2,4 & 8)
DRUGBLS_ILS_E710c 1500mg
\- 6 capsules per day for 8 weeks (week 1,2,4 & 8)
Sponsors
BioLeaders Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 : Safety | up to 9 weeks | Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reid Colposcopic Index | Phase 1 : up to 9 weeks | Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9. |
| 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. |
Countries
South Korea
Outcome results
None listed