Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial
Official title:
A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
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 experimental drug, while 1/3 of participants will receive placebo.
Primary Outcome Measure:
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]
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03196180 -
Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia
|
Early Phase 1 | |
| Active, not recruiting |
NCT04484415 -
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
|
Phase 3 | |
| Not yet recruiting |
NCT06258564 -
The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization
|
||
| Recruiting |
NCT04788849 -
Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples
|
||
| Not yet recruiting |
NCT06273553 -
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02149030 -
Effectiveness of Cervical Screening in HPV Vaccinated Women
|
Phase 4 | |
| Completed |
NCT01550783 -
Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
|
N/A | |
| Enrolling by invitation |
NCT04755517 -
Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women (HPV400)
|
N/A | |
| Completed |
NCT02811367 -
The HPV Self-test as a Test of Cure in Madagascar
|
N/A | |
| Completed |
NCT00081263 -
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
|
Phase 2 | |
| Recruiting |
NCT05405270 -
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
|
||
| Completed |
NCT04312737 -
Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus
|
||
| Completed |
NCT02067468 -
Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia
|
N/A | |
| Completed |
NCT02354534 -
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
|
Phase 1 | |
| Recruiting |
NCT03366493 -
The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection
|
Phase 3 | |
| Active, not recruiting |
NCT03064087 -
Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
|
||
| Recruiting |
NCT05851079 -
Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
|