Clinical trial · Interventional
Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
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)
NCT02195089CI-TRIAL-00021825completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLS_ILB_710c 1000mg | Drug | — | UNRESOLVED |
| BLS_ILS_E710c 1500mg | Drug | — | UNRESOLVED |
| BLS_ILS_E710c 500mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BLS_ILB_E710c 500mg
- description
- * Drug: BLS\_ILB\_E710c 500mg * Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8)
- interventionNames
- Drug: BLS_ILS_E710c 500mg
- type
- EXPERIMENTAL
- label
- BLS_ILS_E710c 1000mg
- description
- * Drug: BLS\_ILS\_E710c 1000mg * Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)
- interventionNames
- Drug: BLS_ILB_710c 1000mg
- type
- EXPERIMENTAL
- label
- BLS_ILS_E710c 1500mg
- description
- * Drug: BLS\_ILS\_E710c 1500mg * Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPark 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. PMID 31576684