Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

Overview

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).

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

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

  • Drug: BLS_ILS_E710c 500mg
    • - 2 capsules per day for 20 days (week 1,2,4 & 8)
  • Drug: BLS_ILB_710c 1000mg
    • - 4 capsules per day for 20 days (week 1,2,4 & 8)
  • Drug: BLS_ILS_E710c 1500mg
    • - 6 capsules per day for 8 weeks (week 1,2,4 & 8)

Arms, Groups and Cohorts

  • Experimental: BLS_ILB_E710c 500mg
    • Drug: BLS_ILB_E710c 500mg Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8)
  • Experimental: BLS_ILS_E710c 1000mg
    • Drug: BLS_ILS_E710c 1000mg Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 & 8)
  • Experimental: BLS_ILS_E710c 1500mg
    • Drug: BLS_ILS_E710c 1500mg Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 & 8)

Clinical Trial Outcome Measures

Primary Measures

  • Phase 1 : Safety
    • Time Frame: up to 9 weeks
    • Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
  • Phase 2a : Regression rate
    • Time Frame: 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 Measures

  • Reid Colposcopic Index
    • Time Frame: Phase 1 : up to 9 weeks
    • Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.
  • Reid Colposcopic Index
    • Time Frame: Phase 2a : up to 16 weeks
    • Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
  • Serum anti-E7 antibody
    • Time Frame: 1 week, 9 weeks, 16 weeks
    • Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.

Participating in This Clinical Trial

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 Eligibility: Female

    Minimum Age: 20 Years

    Maximum Age: 50 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • BioLeaders Corporation
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Jae-Kwan Lee, MD, PhD, Principal Investigator, Korea University Guro Hospital
      • Tae Jin Kim, MD, PhD, Principal Investigator, Kwandong University College of Medicine Cheil Hospital
      • Jong Sup Park, MD, PhD, Principal Investigator, The Catholic University, Korea Seoul St Mary’s Hospital
      • Chi-Heum Cho, MD, PhD, Principal Investigator, The Dongsan Medical Center of Keimyung University
      • Jong Hyeok Kim, MD, PhD, Principal Investigator, Asan Medical Center

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.