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 intraepithelial lesions (HSIL)

Phase 3

Completed

• Conditions: Cervical dysplasia; Cervical intraepithelial neoplasia; 10072990; 10013364

• Registration Number: NL-OMON50923
• Lead Sponsor: GCP-Service International Ltd. & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from
a central laboratory in each region (China, US, and Europe);
2. Adequate colposcopy including:
a. visualization of entire cervical transformation zone including the
squamocolumnar junction
b. visualization of entire lesion margin
3. 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)
4. Average sized uterine cervix (approximately 27 mm in diameter) suitable for
application of the Cevira® device
5. Female (not breastfeeding, with negative pregnancy test and using either a
highly effective method of contraception during the entire study and 30 days
after end of the study or being post-menopausal for at least 1 year or
sterilized women)
6. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
7. Signed written informed consent

Exclusion Criteria

1. Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering
more than half of the uterine cervix area
2. Invasive cervical cancer
3. Adenocarcinoma in situ, or other glandular intraepithelial lesions
4. Lesion(s) extending to the cervical canal (as clinically indicated and
whether to perform endocervical curettage [ECC] test at the discretion of the
investigators)
5. Lesion(s) extending to the vaginal vault
6. Current severe pelvic inflammatory disease, severe cervicitis, or other
severe gynecological infection as per colposcopy and clinical examination
7. Vaginal bleeding at time of treatment at the discretion of the investigator
8. Pregnancy
9. Nursing
10. Childbirth or miscarriage within six weeks of enrolment
11. 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
12. History of toxic shock syndrome
13. Known or suspected porphyria
14. Known allergy to hexaminolevulinate or similar compounds (e.g. methyl
aminolevulinate or aminolevulinic acid)
15. Known allergy to silicone
16. Use of heart pacemaker, and other electronic implants
17. Use of any mechanical barriers such as the contraceptive FemCap
18. Inappropriate anatomical and physiological conditions (natural or acquired
through disease) such as metrorrhagia and causes (myoma, endometrial carcinoma,
polyposis, etc.), uterine/cervical prolapse, vaginal dryness, period of the
woman's menstruation and other
19. Participation in other therapeutic clinical trials using investigational
agents either concurrently or within the last 30 days
20. Patients that in the investigator*s opinion are not suitable for
participation
21. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of responders at 6 months after first treatment;<br /><br>A responder is defined as follows:<br /><br>- Normal histology; or<br /><br>- LSIL histology and clearance of baseline HPV</p><br>