CompletedNCT06439433Updated Jun 3, 2024

ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection

A Phase 2 interventional study of Aminolaevulinic acid (500-mg bottle) and Aminolaevulinic acid (750-mg bottle) in Cervical Intraepithelial Neoplasia Grade 2, Papillomavirus Infections and p16 Protein, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Completed at 5 sites in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 2 years 11 months after the study started (first participant enrolled May 2021, registered May 2024).

Phase: Phase 2
Study type: Interventional
Enrollment: 119
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Female

Study 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 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.

Conditions studied

Cervical Intraepithelial Neoplasia Grade 2
Papillomavirus Infections
p16 Protein

Browse trials for

Papillomavirus Infections 505

In context

Papillomavirus Infections

505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.

This study's enrollment of 119 is below the median of 202 across 338 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Browse Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 119 participants (actual)

Study arms

Experimental
ALA A Group
ALA 500mg Group
Drug: Aminolaevulinic acid (500-mg bottle)
Experimental
ALA B Group
ALA 750mg Group
Drug: Aminolaevulinic acid (750-mg bottle)
Placebo comparator
Placebo
Placebo Group
Drug: Placebo

Interventions

DrugAminolaevulinic acid (500-mg bottle)
once a week for 6 weeks
Also known as: ALA 500mg
DrugAminolaevulinic acid (750-mg bottle)
once a week for 6 weeks
Also known as: ALA 750mg
DrugPlacebo
once a week for 6 weeks

What researchers measure

Primary outcomes

Response rate at week 12 after last treatment
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Time frame: Baseline and week 12 after treatments

Secondary outcomes

Response rate at week 24 after last treatment
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Time frame: 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
Time frame: 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
Time frame: Baseline and week 24 after treatments
Clearance rate of HPV at week 12 after last treatment
Proportion of patients with HPV clearance
Time frame: Baseline and week 12 after treatments
Clearance rate of HPV at week 24 after last treatment
Proportion of patients with HPV clearance
Time frame: Baseline and week 24 after treatments

Other outcomes

Response rate of HPV16 and/or HPV18 positive patients at week 12 after last treatment
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Time frame: Baseline and week 12 after treatments
Response rate of HPV16 and/or HPV18 positive patients at week 24 after last treatment
"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Time frame: Baseline and week 24 after treatments

Study locations

5 sites

Peking University Third Hospital
Beijing, Beijing Municipality 100191, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000, China
Qilu Hospital of Shandong University
Jinan, Shandong 250012, China
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality 200011, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality 200120, China

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2021 to primary completion in Dec 2023, 30 months.

Of 28 phase 2 interventional studies under Papillomavirus Infections, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 80. This study's 30 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: May 28, 2024
First posted: Jun 3, 2024
StartActual: May 31, 2021
Primary completionActual: Dec 20, 2023
CompletionActual: Mar 6, 2024
Last update: Jun 3, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06439433
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jun 3, 2024
Start date: May 31, 2021
Primary completion: Dec 20, 2023
Completion: Mar 6, 2024
Last update: Jun 3, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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