임상 레이더 AI | ||
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임상시험 NCT07493824은(는) Persistent HR-HPV Infection of the Cervix에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection 4상 115
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07493824은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Persistent HR-HPV Infection of the Cervix에 대해 진행되며, 4상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 7월 24일에 시작되어 115명의 참여자를 모집하고 있습니다. The First Hospital of Jilin University이(가) 진행하며, 2028년 5월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 25일에 갱신되었습니다.
간단한 개요
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection
상세한 설명
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...더 보기
공식 제목
Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection
질환명
Persistent HR-HPV Infection of the Cervix기타 연구 식별자
- 25K186-001
NCT 번호
실제 연구 시작일
2025-07-24
최신 업데이트 게시
2026-03-25
예상 연구 완료일
2028-05-31
계획된 등록 인원
115
연구종류
중재연구
단계/상
4상
상태
모집중
키워드
Patling ® Antibacterial Liquid
Treatment for persistent HPV infection
Treatment for persistent HPV infection
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Single-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 |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
26 Years
참여 가능한 성별
여성
- 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.
연구 책임자
Songling Zhang, 책임연구자, vice president, The First Hospital of Jilin University
연구 대표 연락처
연락처: Xiaosen Li Li, +8618343116682, [email protected]
1 1개국에 임상시험 장소
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130000, China
Zhentong Wei Medic, 연락처, 15804300686, [email protected]
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