ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection
NCT ID: NCT06439433
Last Updated: 2024-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
119 participants
INTERVENTIONAL
2021-05-31
2024-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALA A Group
ALA 500mg Group
Aminolaevulinic acid (500-mg bottle)
once a week for 6 weeks
ALA B Group
ALA 750mg Group
Aminolaevulinic acid (750-mg bottle)
once a week for 6 weeks
Placebo
Placebo Group
Placebo
once a week for 6 weeks
Interventions
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Aminolaevulinic acid (500-mg bottle)
once a week for 6 weeks
Aminolaevulinic acid (750-mg bottle)
once a week for 6 weeks
Placebo
once a week for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months
* Intense desire to retain the cervical structure or function
* High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months
* Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
* Signed written informed consent
Exclusion Criteria
* Invasive carcinoma possibility or lesions extending to the vaginal wall
* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
* Undiagnosed vaginal bleeding within the last 3 months
* With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
* With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[ULN\], or total bilirubin \> 1.5 ULN, or serum creatinine or blood urea nitrogen \> 1.5 ULN)
* History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months
* Pregnancy or nursing
* Participation in any clinical studies within the last 30 days
* Poor compliance or inability to complete the trial
* Subjects that the investigators judged to be not suitable to participate the study besides above
18 Years
45 Years
FEMALE
No
Sponsors
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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FDZJYX-ALA-202001
Identifier Type: -
Identifier Source: org_study_id
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