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

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Cervical Intraepithelial Neoplasia Grade 2; p16 Protein; Papillomavirus Infections

Treatments: Drug: Aminolaevulinic acid (500-mg bottle); Drug: Aminolaevulinic acid (750-mg bottle); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06439433

FDZJYX-ALA-202001

Details and patient eligibility

About

Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.

Full 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.

Enrollment: 119 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 3 patient groups, including a placebo group

ALA A Group

Experimental group

Description:

ALA 500mg Group

Treatment:

Drug: Aminolaevulinic acid (500-mg bottle)

ALA B Group

Experimental group

Description:

ALA 750mg Group

Treatment:

Drug: Aminolaevulinic acid (750-mg bottle)

Placebo

Placebo Comparator group

Description:

Placebo Group

Treatment:

Drug: Placebo