A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
NCT ID: NCT03274206
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
126 participants
INTERVENTIONAL
2017-08-30
2020-08-31
Brief Summary
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Detailed Description
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Complete histopathological regression from baseline \[Time Frame: Baseline through Week 16\]
Secondary Outcome Measures:
* Change from baseline of CIN classification \[Time Frame: Baseline through Week 16\]
* Change from baseline of RCI \[Time Frame: Baseline through Week 16 and Week 32\]
* Change from baseline of cytopathological classification based on bethesda system \[Time Frame: Baseline through Week 16 and Week 32\]
* Change from baseline as compared to placebo in the expression rate of P16/Ki-67 \[Time Frame: Baseline through Week 16\]
* Change from baseline as compared to placebo of the number of CD8 positive cells in the cervical tissue \[Time Frame: Baseline through Week 16\]
* Change from baseline as compared to placebo in HPV 16 clearance rate
* Change of RCI based on the histopathological regression at Week 16 \[Time Frame: Week 16 through Week 32\]
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BLS-ILB-E710c
* Drug: BLS-ILB-E710c 1,000mg
* Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
BLS-ILB-E710c
BLS-ILB-E710c 250mg/capsule
BLS-ILB-E710c-placebo
* Drug: BLS-ILB-E710c-placebo
* Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
Placebo
BLS-ILB-E710c-placebo
Interventions
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BLS-ILB-E710c
BLS-ILB-E710c 250mg/capsule
Placebo
BLS-ILB-E710c-placebo
Eligibility Criteria
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Inclusion Criteria
* Subjects who are infected with HPV 16 type only or with HPV 16 type and any other types listed below
1\) low risk type of HPV, 2) HPV 16-related type
* Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by colposcopic biopsy within 6 weeks before enrollment
* All lesions must be observable by colposcopy and CIN2 or higher lesion must be less than 1/2 in the transformation zone area
* Willing to use adequate contraception methods during the study period
* Eligible based on screening test results
* Normal electrocardiogram
* Voluntarily signed informed consent form
Exclusion Criteria
* Presence of adenocarcinoma or glandular lesion in the cervix
* Subjects who are infected with HPV type 18-related type
* Subjects with autoimmune disease
* Current or prior treatment past 2 months with immunosuppressant therapies
* Hypersensitive to the investigational drug
* Subjects who currently have acute diseases that require medical attention
* Participation in other studies involving investigational drug(s) or investigational device(s) within 3 months
* Currently having chronic pancreatitis or diagnosed with acute pancreatitis
* Currently having underlying diseases including inflammatory intestinal diseases and tumors, ulcer, bleeding or puncture in the gastrointestinal tract
* Pregnant or breastfeeding
* Subjects with active or inactive hepatitis, or infectious disease
* History of HIV infection
* History of therapeutic HPV vaccination
* Subjects who require continuous use of antibiotics
* Administration of blood product within 3 months before signing informed consent form
* History of vaccination within 2 months before signing informed consent form (4 months in case of live vaccine)
20 Years
49 Years
FEMALE
No
Sponsors
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BioLeaders Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jae-Kwan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Ansan Hospital
Ansan, Geyonggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
The Dongsan Medical Center of Keimyung Hospital
Daegu, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei Unversity Health System
Seoul, , South Korea
University of Ulsan College of Medicine, Asan Medical Center
Seoul, , South Korea
Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hallym University Medical Center
Seoul, , South Korea
Kwandong University College of Medicine Cheil Hospital
Seoul, , South Korea
CHA Gangnam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seung Hun Song, MD, PhD
Role: primary
Jae-Weon Kim, MD, PhD
Role: primary
Yeon-Jae Han
Role: backup
Yong-Man Kim, MD, Ph.D
Role: primary
Geum-hee Nah
Role: backup
Seok Ju Seong, MD, PhD
Role: primary
Other Identifiers
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12591
Identifier Type: OTHER
Identifier Source: secondary_id
BLS-ILB-E710c-202
Identifier Type: -
Identifier Source: org_study_id
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