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

Papillomavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06439433
• Other study ID #: FDZJYX-ALA-202001
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2021
• Est. completion date: March 6, 2024

Study information

• Verified date: May 2024
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 6, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia Grade 2
• Communicable Diseases
• Infections
• Neoplasms
• p16 Protein
• Papillomavirus Infections
• Uterine Cervical Dysplasia

Intervention

Drug:
• Aminolaevulinic acid (500-mg bottle)
once a week for 6 weeks
• Aminolaevulinic acid (750-mg bottle)
once a week for 6 weeks
• Placebo
once a week for 6 weeks

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline and week 12 after treatments
Other	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	Baseline and week 24 after treatments
Primary	Response rate at week 12 after last treatment	"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1	Baseline and week 12 after treatments
Secondary	Response rate at week 24 after last treatment	"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1	Baseline and week 24 after treatments
Secondary	Cure rate at week 12 after last treatment	"Cure" is defined as: pathology showed normal or only inflammatory changes	Baseline and week 12 after treatments
Secondary	Cure response rate at week 24 after last treatment	"Cure" is defined as: pathology showed normal or only inflammatory changes	Baseline and week 24 after treatments
Secondary	Clearance rate of HPV at week 12 after last treatment	Proportion of patients with HPV clearance	Baseline and week 12 after treatments
Secondary	Clearance rate of HPV at week 24 after last treatment	Proportion of patients with HPV clearance	Baseline and week 24 after treatments