Cervical Intraepithelial Neoplasia Grade 2Phase 2NCT06439433
ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection
A Phase 2 study testing Aminolaevulinic acid (500-mg bottle) and Aminolaevulinic acid (750-mg bottle) in people with Cervical Intraepithelial Neoplasia Grade 2 and Papillomavirus Infections, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2, Papillomavirus Infections, p16 Protein
- What is being tested?
- Aminolaevulinic acid (500-mg bottle) and Aminolaevulinic acid (750-mg bottle)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 5 sitesChina
- Study dates
- 31 May 2021to 6 Mar 2024
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women, 18-45 years of age
- Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months
- Intense desire to retain the cervical structure or function
- High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months
- Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
- Signed written informed consent
Who cannot join
- Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or lesions extending to the vaginal wall
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding within the last 3 months
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
- With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years
Show all 12Show fewer
- Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase > 3 upper limit of normal [ULN], or total bilirubin > 1.5 ULN, or serum creatinine or blood urea nitrogen > 1.5 ULN)
- History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months
- Pregnancy or nursing
- Participation in any clinical studies within the last 30 days
- Poor compliance or inability to complete the trial
- Subjects that the investigators judged to be not suitable to participate the study besides above
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200120
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIc Clinical Trial of ALA-PDT in Patients With Cervical Intraepithelial Neoplasia Grade 2 (CIN2) in p16-positivity and High-risk HPV Infection
Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
Read the detailed description
A multi-center, randomized, double-blind, placebo-controlled phase IIc clinical trial of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
- Being tested
- Aminolaevulinic acid (500-mg bottle), Aminolaevulinic acid (750-mg bottle), Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolaevulinic acid (500-mg bottle)Drug
Also called ALA 500mg
once a week for 6 weeks
Aminolaevulinic acid (750-mg bottle)Drug
Also called ALA 750mg
once a week for 6 weeks
PlaceboDrug
once a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| ALA A Group | Experimental | ALA 500mg Group Receives: Drug: Aminolaevulinic acid (500-mg bottle) |
| ALA B Group | Experimental | ALA 750mg Group Receives: Drug: Aminolaevulinic acid (750-mg bottle) |
| Placebo | Placebo comparator | Placebo Group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate at week 12 after last treatment
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Measured: Baseline and week 12 after treatments
Secondary outcomes (5)
Response rate at week 24 after last treatment
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Measured: Baseline and week 24 after treatments
Cure rate at week 12 after last treatment
"Cure" is defined as: pathology showed normal or only inflammatory changes
Measured: Baseline and week 12 after treatments
Cure response rate at week 24 after last treatment
"Cure" is defined as: pathology showed normal or only inflammatory changes
Measured: Baseline and week 24 after treatments
Clearance rate of HPV at week 12 after last treatment
Proportion of patients with HPV clearance
Measured: Baseline and week 12 after treatments
Clearance rate of HPV at week 24 after last treatment
Proportion of patients with HPV clearance
Measured: Baseline and week 24 after treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start31 May 2021
- Primary completion20 Dec 2023
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439433
- Sponsor's protocol ID
- FDZJYX-ALA-202001
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIc Clinical Trial of ALA-PDT in Patients With Cervical Intraepithelial Neoplasia Grade 2 (CIN2) in p16-positivity and High-risk HPV Infection
- ClinicalTrials.gov ID
- NCT06439433
- Acronym / sponsor ID
- FDZJYX-ALA-202001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 3 Jun 2024 (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.
Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
Detailed description
A multi-center, randomized, double-blind, placebo-controlled phase IIc clinical trial of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALA A Group | Experimental | Drug: Aminolaevulinic acid (500-mg bottle)ALA 500mg Group |
| ALA B Group | Experimental | Drug: Aminolaevulinic acid (750-mg bottle)ALA 750mg Group |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Premenopausal women, 18-45 years of age
- Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months
- Intense desire to retain the cervical structure or function
- High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months
- Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
Key exclusion criteria (12 listed)
- Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- Invasive carcinoma possibility or lesions extending to the vaginal wall
- Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- Undiagnosed vaginal bleeding within the last 3 months
- With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
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 |
|---|---|---|
| Aminolaevulinic acid (500-mg bottle)Also: ALA 500mgonce a week for 6 weeks | Drug | ALA A Group |
| Aminolaevulinic acid (750-mg bottle)Also: ALA 750mgonce a week for 6 weeks | Drug | ALA B Group |
| Placeboonce a week for 6 weeks | Drug | Placebo |
Primary outcome
Response rate at week 12 after last treatment
Time frame: Baseline and week 12 after treatments
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
5 secondary outcomes
Response rate at week 24 after last treatment
Time frame: Baseline and week 24 after treatments
Cure rate at week 12 after last treatment
Time frame: Baseline and week 12 after treatments
Cure response rate at week 24 after last treatment
Time frame: Baseline and week 24 after treatments
Clearance rate of HPV at week 12 after last treatment
Time frame: Baseline and week 12 after treatments
Clearance rate of HPV at week 24 after last treatment
Time frame: Baseline and week 24 after treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
Related trials for Cervical Intraepithelial Neoplasia Grade 2
Not yet recruitingObservational study
RWS of PDT for CIN 2
Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
Recruiting
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2
Active, not recruitingPhase 2
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma In Situ
Recruiting
Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance
Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2
Recruiting
Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
Cervical Cancer, CIN2
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminolaevulinic acid (500-mg bottle) and Aminolaevulinic acid (750-mg bottle) in people with Cervical Intraepithelial Neoplasia Grade 2 and Papillomavirus Infections, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 5 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate at week 12 after last treatment (time frame: Baseline and week 12 after treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2024.