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

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ClinicalTrials.gov Identifier: NCT04484415
Recruitment Status : Active, not recruiting
First Posted : July 23, 2020
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu Yahong Meditech Co., Ltd aka Asieris ( Asieris MediTech (Hong Kong) Co., Ltd. )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Grade 2/3 Combination Product: Cevira® Combination Product: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cevira® treatment
The Cevira® treatment is an integrated combination of drug and device
 Combination Product: Cevira®
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.
Placebo Comparator: Placebo ointment
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
The placebo device is identical in appearance as the Cevira® device, but does not provide light.


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of responders at 6 months after first treatment [ Time Frame: 6 months ]

    A responder is defined as follows:

    • Normal histology; or
    • LSIL histology and clearance of baseline HPV


Secondary Outcome Measures :
  1. The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment. [ Time Frame: 6 months ]
    The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.

  2. The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment. [ Time Frame: 6 months ]
    The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.

  3. The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment. [ Time Frame: 6 months ]
    The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.

  4. The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment. [ Time Frame: 6 months ]
    The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484415


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China
Sponsors and Collaborators
Asieris MediTech (Hong Kong) Co., Ltd.
Investigators
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Principal Investigator: Jinghe Lang, MD,PhD Peking Union Medical College Hospital
Study Chair: John Zhuang, PhD Asieris MediTech (Hong Kong) Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Asieris MediTech (Hong Kong) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04484415    
Other Study ID Numbers: YHGT-CEV-R1
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Neoplasms
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases