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De klinische studie NCT07493824 voor Persistent HR-HPV Infection of the Cervix is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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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 Fase 4 115

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De klinische studie NCT07493824 onderzoekt behandeling bij Persistent HR-HPV Infection of the Cervix. Deze Fase 4 interventioneel-studie heeft de status rekruterend. Het doel is om 115 deelnemers te includeren vanaf 24 juli 2025. De studie wordt geleid door The First Hospital of Jilin University en de voltooiing is gepland op 31 mei 2028. Laatste update op ClinicalTrials.gov: 25 maart 2026.
Beknopte samenvatting
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection
Uitgebreide beschrijving
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...Toon meer
Officiële titel

Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection

Aandoeningen
Persistent HR-HPV Infection of the Cervix
Andere studie-ID's
  • 25K186-001
NCT-ID
NCT07493824
Startdatum (Werkelijk)
2025-07-24
Laatste update geplaatst
2026-03-25
Verwachte einddatum
2028-05-31
Inschrijving (Geschat)
115
Studietype
Interventioneel
FASE
Fase 4
Status
Rekruterend
Trefwoorden
Patling ® Antibacterial Liquid
Treatment for persistent HPV infection
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelSingle-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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
26 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
  • 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.
The First Hospital of Jilin University logoThe First Hospital of Jilin University
Verantwoordelijke instantie
Songling Zhang, Hoofdonderzoeker, vice president, The First Hospital of Jilin University
Centraal Contactpersoon
Contact: Xiaosen Li Li, +8618343116682, [email protected]
1 Studielocaties in 1 landen

Jilin

The First Hospital of Jilin University, Changchun, Jilin, 130000, China
Zhentong Wei Medic, Contact, 15804300686, [email protected]
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