Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

Brief Title

Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

Official Title

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)

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 intraepithelial lesions (HSIL).
    

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 of them will be enrolled in China.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

The proportion of responders at 6 months after first treatment

Secondary Outcome

 The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.

Condition

Cervical Intraepithelial Neoplasia Grade 2/3

Intervention

Cevira®

Study Arms / Comparison Groups

 Cevira® treatment

Description:  The Cevira® treatment is an integrated combination of drug and device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Combination Product

Estimated Enrollment

384

Start Date

September 2020

Completion Date

September 2022

Primary Completion Date

September 2021

Eligibility Criteria

        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:

               1. visualization of entire cervical transformation zone including the squamocolumnar
                  junction

               2. 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 suitable for application of the Cevira® device

          5. Use of adequate birth control until completion of the 6 month assessment visit

          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

         17. Participation in other therapeutic clinical trials using investigational agents either
             concurrently or within the last 30 days

         18. Patients that in the investigator's opinion are not suitable for participation

         19. 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
      

Gender

Female

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Jinghe Lang, MD,PhD, +8613816002336, [email protected]

NCT ID

NCT04484415

Organization ID

YHGT-CEV-R1

Responsible Party

Sponsor

Study Sponsor

Asieris MediTech (Hong Kong) Co., Ltd.

Study Sponsor

Jinghe Lang, MD,PhD, Principal Investigator, Peking Union Medical College Hospital

Verification Date

July 2020