Status:
UNKNOWN
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
Lead Sponsor:
Asieris MediTech (Hong Kong) Co., Ltd.
Conditions:
Cervical Intraepithelial Neoplasia Grade 2/3
Eligibility:
FEMALE
18-85 years
Phase:
PHASE3
Brief Summary
A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithel...
Detailed Description
To evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.A total of 384 subjects will be enrolled globally, among which, 300 subjects o...
Eligibility Criteria
Inclusion
- Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from a central laboratory in each region (China, US, and Europe);
- Adequate colposcopy including:
- visualization of entire cervical transformation zone including the squamocolumnar junction
- visualization of entire lesion margin
- Colposcopically visible lesion after biopsy, before treatment (Note: To ensure a colposcopically visible lesion after biopsy, the lesion should cover approximately 15% of the uterine cervix before biopsy)
- Average sized uterine cervix suitable for application of the Cevira® device
- Use of adequate birth control until completion of the 6 month assessment visit
- Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
- Signed written informed consent
Exclusion
- Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of the uterine cervix area
- Invasive cervical cancer
- Adenocarcinoma in situ, or other glandular intraepithelial lesions
- Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage \[ECC\] test at the discretion of the investigators)
- Lesion(s) extending to the vaginal vault
- Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infection as per colposcopy and clinical examination
- Vaginal bleeding at time of treatment at the discretion of the investigator
- Pregnancy
- Nursing
- Childbirth or miscarriage within six weeks of enrolment
- Patients who previously received surgical treatment, have incomplete cervical structure and have recurrent HSIL; or patients who received other treatment after the confirmed diagnosis of HSIL
- History of toxic shock syndrome
- Known or suspected porphyria
- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- Known allergy to silicone
- Use of heart pacemaker
- Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days
- Patients that in the investigator's opinion are not suitable for participation
- Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04484415
Start Date
November 10 2020
End Date
December 1 2023
Last Update
August 12 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China