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Clinical Trial NCT07493824 for Persistent HR-HPV Infection of the Cervix is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection Phase 4 115
Clinical Trial NCT07493824 is designed to study Treatment for Persistent HR-HPV Infection of the Cervix. It is a Phase 4 interventional study that is recruiting, having started on 24 July 2025, with plans to enroll 115 participants. Led by The First Hospital of Jilin University, it is expected to complete by 31 May 2028. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection
Detailed Description
This study is a single-arm, single-center clinical study ® The study was designed to determine the safety of Patelin antibacterial solution in patients with persistent cervical HR-HPV infection availability. The study primarily aims to evaluate the seroconversion rate of cervical HR-HPV in persistent HR-HPV carriers; simultaneously, it compares the positivity rates and copy levels of HPV E6/E7mRNA, changes in gynecol...Show More
Official Title
Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection
Conditions
Persistent HR-HPV Infection of the CervixOther Study IDs
- 25K186-001
NCT ID Number
Start Date (Actual)
2025-07-24
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-05-31
Enrollment (Estimated)
115
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Patling ® Antibacterial Liquid
Treatment for persistent HPV infection
Treatment for persistent HPV infection
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSingle-arm, prospective study of the efficacy and safety of Paiteling®Antibacterial Liquid in the tr | Patling ® Antibacterial Liquid Apply Patling ® antibacterial solution locally to the cervix |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection | Cervical HR-HPV persistent infection HR-HPV seroconversion rate:
5 The rate of turning negative: refers to the reexamination of patients' HR-HPV at a specified time after the end of treatment. Turning negative is defined as the reversal of HR-HPV from persistently positive at enrollment to negative, including all HR-HPV being negative and the reversal of persistently positive HR-HPV to negative while other subtypes are positive. The HR-HPV of the subjects was reviewed 12 months after treatment, and the seroconversion rate of the subtypes of HR-HPV infection that persisted at the time of enrollment was observed and recorded, defined as the seroconversion at that time point. | 24 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
26 Years
Eligible Sexes
Female
- 1 、 Age 25 to 65 years (inclusive), persistent cervical HR-HPV infection (HR-HPV persistent infection refers to infection with the same high-risk HPV subtypes for ≥2 years (this can be from different testing companies; for multiple infections, only one subtyping of HPV persistence is required)); if the cervical biopsy shows chronic cervicitis or low-grade cervical intraepithelial neoplasia; 2. Sexual history; 3. No relevant anti-HPV virus treatment (vaginal or systemic) in the 3 months prior to visit; 4. No pregnancy plan within 6 months of visit 5、 Voluntary signing of informed consent.
- 1、 Cervical biopsy results of TCT or HSIL; 2 、 Cervical HR-HPV infection subtypes changed or reversed to negative; 3. Pregnant or lactating women; 4. Acute inflammation of the genital tract; 5Recent immunodeficiency (chemoradiotherapy, AIDS, SLE); 6. Patients with severe diseases such as diabetes, cardiovascular disease, brain, liver, kidney and hematopoietic system, and mental illness; 7. Those with a history of drug allergy and allergic constitution; 8 Patients who have participated in other clinical trials in the last three months; 9. Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in work environment and unstable living environment that are likely to cause loss of follow-up, according to the investigator's judgment.
Study Responsible Party
Songling Zhang, Principal Investigator, vice president, The First Hospital of Jilin University
Study Central Contact
Contact: Xiaosen Li Li, +8618343116682, [email protected]
1 Study Locations in 1 Countries
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130000, China
Zhentong Wei Medic, Contact, 15804300686, [email protected]
Recruiting