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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BLS_ILS_E710c 500mg
BLS_ILB_710c 1000mg
BLS_ILS_E710c 1500mg
Sponsored by
BioLeaders Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring Treatment of Cervical Intraepithelial Neoplasia(CIN3)

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Dongsan Medical Center of Keimyung University
  • Kwandong University College of Medicine Cheil Hospital
  • The Catholic University, Korea Seoul St Mary's Hospital
  • Asan Medical Center
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BLS_ILB_E710c 500mg

BLS_ILS_E710c 1000mg

BLS_ILS_E710c 1500mg

Arm Description

Drug: BLS_ILB_E710c 500mg Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8)

Drug: BLS_ILS_E710c 1000mg Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 & 8)

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

Outcomes

Primary Outcome Measures

Phase 1 : Safety
Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
Phase 2a : Regression rate
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 Outcome Measures

Reid Colposcopic Index
Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.
Reid Colposcopic Index
Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
Serum anti-E7 antibody
Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.

Full Information

First Posted
July 15, 2014
Last Updated
April 18, 2016
Sponsor
BioLeaders Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02195089
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioLeaders Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
Treatment of Cervical Intraepithelial Neoplasia(CIN3)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLS_ILB_E710c 500mg
Arm Type
Experimental
Arm Description
Drug: BLS_ILB_E710c 500mg Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8)
Arm Title
BLS_ILS_E710c 1000mg
Arm Type
Experimental
Arm Description
Drug: BLS_ILS_E710c 1000mg Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 & 8)
Arm Title
BLS_ILS_E710c 1500mg
Arm Type
Experimental
Arm Description
Drug: BLS_ILS_E710c 1500mg Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 & 8)
Intervention Type
Drug
Intervention Name(s)
BLS_ILS_E710c 500mg
Other Intervention Name(s)
CIN3 Theraputic Vaccine
Intervention Description
- 2 capsules per day for 20 days (week 1,2,4 & 8)
Intervention Type
Drug
Intervention Name(s)
BLS_ILB_710c 1000mg
Other Intervention Name(s)
CIN3 Theraputic Vaccine
Intervention Description
- 4 capsules per day for 20 days (week 1,2,4 & 8)
Intervention Type
Drug
Intervention Name(s)
BLS_ILS_E710c 1500mg
Other Intervention Name(s)
CIN3 Theraputic Vaccine
Intervention Description
- 6 capsules per day for 8 weeks (week 1,2,4 & 8)
Primary Outcome Measure Information:
Title
Phase 1 : Safety
Description
Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
Time Frame
up to 9 weeks
Title
Phase 2a : Regression rate
Description
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
Time Frame
screening and 9 weeks(option), 16 weeks.
Secondary Outcome Measure Information:
Title
Reid Colposcopic Index
Description
Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.
Time Frame
Phase 1 : up to 9 weeks
Title
Reid Colposcopic Index
Description
Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
Time Frame
Phase 2a : up to 16 weeks
Title
Serum anti-E7 antibody
Description
Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.
Time Frame
1 week, 9 weeks, 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Kwan Lee, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae Jin Kim, MD, PhD
Organizational Affiliation
Kwandong University College of Medicine Cheil Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Sup Park, MD, PhD
Organizational Affiliation
The Catholic University, Korea Seoul St Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi-Heum Cho, MD, PhD
Organizational Affiliation
The Dongsan Medical Center of Keimyung University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Hyeok Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Dongsan Medical Center of Keimyung University
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Kwandong University College of Medicine Cheil Hospital
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
Facility Name
The Catholic University, Korea Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31576684
Citation
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.
Results Reference
derived

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

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