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

NCT04484415 | Unknown Phase 3 DMC

• 1 other identifier: YHGT-CEV-R1
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Outcome Measures

Primary Outcomes (1)

• The proportion of responders at 6 months after first treatment

  A responder is defined as follows: * Normal histology; or * LSIL histology and clearance of baseline HPV

  6 months

Secondary Outcomes (4)

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

  6 months

• The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.

  6 months

• The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.

  6 months

• The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.

  6 months

Study Arms (2)

Cevira® treatment

EXPERIMENTAL

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

Combination Product: Cevira®

Placebo ointment

PLACEBO COMPARATOR

The placebo ointment contains only vehicle, and is similar in appearance and consistence as the Cevira® ointment. The placebo device is identical in appearance as the Cevira® device, but does not provide light.

Combination Product: Placebo

Interventions

Cevira® COMBINATION_PRODUCT

The device is a single-use, disposable, LED-based red light source. The device will automatically switch on the light 5 hours after administration, and provide continuous photoactivation of 125 J/cm2 over 4.6 hours before automatically shutting down.

Cevira® treatment

Placebo COMBINATION_PRODUCT

The placebo device is identical in appearance as the Cevira® device, but does not provide light.

Placebo ointment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asieris MediTech (Hong Kong) Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Chen F, Novak Z, Dannecker C, Mokras C, Sui L, Zhang Y, You Z, Han L, Lang J, Hillemanns P. Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraepithelial lesion: APRICITY phase 3 study protocol. BMJ Open. 2022 Jun 6;12(6):e061740. doi: 10.1136/bmjopen-2022-061740.

  PMID: 35667715 DERIVED

Study Officials

• Jinghe Lang, MD,PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• John Zhuang, PhD

  Asieris MediTech (Hong Kong) Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: November 10, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)