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

April 18, 2016 updated by: BioLeaders Corporation

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • The Dongsan Medical Center of Keimyung University
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 100-380
        • Kwandong University College of Medicine Cheil Hospital
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University, Korea Seoul St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: BLS_ILS_E710c 500mg
- 2 capsules per day for 20 days (week 1,2,4 & 8)
Other Names:
  • CIN3 Theraputic Vaccine
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)
Drug: BLS_ILB_710c 1000mg
- 4 capsules per day for 20 days (week 1,2,4 & 8)
Other Names:
  • CIN3 Theraputic Vaccine
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)
Drug: BLS_ILS_E710c 1500mg
- 6 capsules per day for 8 weeks (week 1,2,4 & 8)
Other Names:
  • CIN3 Theraputic Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 : Safety
Time Frame: up to 9 weeks
Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
up to 9 weeks
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
screening and 9 weeks(option), 16 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Phase 1 : up to 9 weeks
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
Phase 2a : up to 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.
1 week, 9 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioLeaders Corporation

Investigators

  • Principal Investigator: Jong Hyeok Kim, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMT2013-BLS-ILB-E710c
  • 12591 (Other Identifier: Ministry of Food and Drug Safety)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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