Status:
UNKNOWN
A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
Lead Sponsor:
BioLeaders Corporation
Conditions:
Cervical Intraepithelial Neoplasia Grade 2/3
Eligibility:
FEMALE
20-49 years
Phase:
PHASE2
Brief Summary
This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will receive the experimenta...
Detailed Description
Primary Outcome Measure: Complete histopathological regression from baseline \[Time Frame: Baseline through Week 16\] Secondary Outcome Measures: * Change from baseline of CIN classification \[Time...
Eligibility Criteria
Inclusion
- Fertile female aged between 20 and 49
- 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
- Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious invation
- 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)
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03274206
Start Date
August 30 2017
End Date
August 1 2020
Last Update
February 7 2020
Active Locations (14)
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1
Korea University Ansan Hospital
Ansan, Geyonggi-do, South Korea, 15355
2
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea, 13496
3
Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
4
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea, 11765