Cervical Intraepithelial Neoplasia Grade 2/3Phase 3APRICITYNCT04484415
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
A Phase 3 study testing Cevira® in people with Cervical Intraepithelial Neoplasia Grade 2/3, run by Asieris MediTech (Hong Kong) Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3
- What is being tested?
- Cevira®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Being tested
- Cevira®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboCombination product
The placebo device is identical in appearance as the Cevira® device, but does not provide light.
| Study group | Role | What they receive |
|---|---|---|
| Cevira® treatment | Experimental | The Cevira® treatment is an integrated combination of drug and device Receives: 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. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.
The proportion of HPV positive patients with clearance of baseline HPV at 6 months after first treatment.
Measured: 6 months
The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.
The proportion of HPV16 positive patients with clearance of HPV16 at 6 months after first treatment.
Measured: 6 months
The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.
The proportion of HPV16 and/or HPV18 positive patients with clearance of baseline HPV at 6 months after first treatment.
Measured: 6 months
The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.
The proportion of patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start10 Nov 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2/3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asieris MediTech (Hong Kong) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinghe Lang, MD,PhD, Principal investigator, Peking Union Medical College HospitalJohn Zhuang, PhD, Study chair, Asieris MediTech (Hong Kong) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484415
- Sponsor's protocol ID
- YHGT-CEV-R1
- Acronym
- APRICITY
- Status last verified
- Aug 2022
- First submitted
- 20 Jul 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35667715
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04484415
- Acronym / sponsor ID
- APRICITY / YHGT-CEV-R1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Asieris MediTech (Hong Kong) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cevira® treatment | Experimental | Combination Product: Cevira®The Cevira® treatment is an integrated combination of drug and device |
| Placebo ointment | Placebo comparator | Combination Product: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Cevira® treatment |
| PlaceboThe placebo device is identical in appearance as the Cevira® device, but does not provide light. | Combination product | Placebo ointment |
Primary outcome
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
4 secondary outcomes
The proportion of HPV positive patients with clearance of baseline HPV 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.
Time frame: 6 months
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 patients with histologic regression, defined as LSIL or normal histology, at 6 months after first treatment.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Derived from this study: PubMed 35667715Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinghe Lang, MD,PhD principal investigator
Peking Union Medical College Hospital
John Zhuang, PhD study chair
Asieris MediTech (Hong Kong) Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cevira® in people with Cervical Intraepithelial Neoplasia Grade 2/3, run by Asieris MediTech (Hong Kong) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of responders at 6 months after first treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04484415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.