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

Cervical Intraepithelial Neoplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195089
• Other study ID #: UMT2013-BLS-ILB-E710c
• Secondary ID: 12591
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 15, 2014
• Last updated: April 18, 2016
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: BioLeaders Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The Dongsan Medical Center of Keimyung University	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kwandong University College of Medicine Cheil Hospital	Seoul
Korea, Republic of	The Catholic University, Korea Seoul St Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
BioLeaders Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 : Safety	Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0	up to 9 weeks	No
Primary	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	screening and 9 weeks(option), 16 weeks.	No
Secondary	Reid Colposcopic Index	Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.	Phase 1 : up to 9 weeks	Yes
Secondary	Reid Colposcopic Index	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	No
Secondary	Serum anti-E7 antibody	Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.	1 week, 9 weeks, 16 weeks	No