Cervical Intraepithelial Neoplasia Grade 2, p16 Protein, Papillomavirus Infections
Conditions
Brief summary
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.
Interventions
DRUGAminolaevulinic acid (500-mg bottle)
once a week for 6 weeks
DRUGAminolaevulinic acid (750-mg bottle)
once a week for 6 weeks
DRUGPlacebo
once a week for 6 weeks
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate at week 12 after last treatment | Baseline and week 12 after treatments | Response is defined as: pathology showed normal or only inflammatory changes or CIN1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance rate of HPV at week 12 after last treatment | Baseline and week 12 after treatments | Proportion of patients with HPV clearance |
| Response rate at week 24 after last treatment | Baseline and week 24 after treatments | Response is defined as: pathology showed normal or only inflammatory changes or CIN1 |
| Cure rate at week 12 after last treatment | Baseline and week 12 after treatments | Cure is defined as: pathology showed normal or only inflammatory changes |
| Cure response rate at week 24 after last treatment | Baseline and week 24 after treatments | Cure is defined as: pathology showed normal or only inflammatory changes |
| Clearance rate of HPV at week 24 after last treatment | Baseline and week 24 after treatments | Proportion of patients with HPV clearance |
Other
| Measure | Time frame | Description |
|---|---|---|
| Response rate of HPV16 and/or HPV18 positive patients at week 12 after last treatment | Baseline and week 12 after treatments | Response is defined as: pathology showed normal or only inflammatory changes or CIN1 |
| Response rate of HPV16 and/or HPV18 positive patients at week 24 after last treatment | Baseline and week 24 after treatments | Response is defined as: pathology showed normal or only inflammatory changes or CIN1 |
Countries
China
Outcome results
None listed