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

NCT06439433 | Completed Phase 2

• 1 other identifier: FDZJYX-ALA-202001
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 5

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.

Conditions

Cervical Intraepithelial Neoplasia Grade 2; Papillomavirus Infections; p16 Protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Response rate at week 24 after last treatment

  Baseline and week 24 after treatments

• Cure rate at week 12 after last treatment

  Baseline and week 12 after treatments

• Cure response rate at week 24 after last treatment

  Baseline and week 24 after treatments

• Clearance rate of HPV at week 12 after last treatment

  Baseline and week 12 after treatments

• Clearance rate of HPV at week 24 after last treatment

  Baseline and week 24 after treatments

Other Outcomes (2)

• Response rate of HPV16 and/or HPV18 positive patients at week 12 after last treatment

  Baseline and week 12 after treatments

• Response rate of HPV16 and/or HPV18 positive patients at week 24 after last treatment

  Baseline and week 24 after treatments

Study Arms (3)

ALA A Group

EXPERIMENTAL

ALA 500mg Group

Drug: Aminolaevulinic acid (500-mg bottle)

ALA B Group

EXPERIMENTAL

ALA 750mg Group

Drug: Aminolaevulinic acid (750-mg bottle)

Placebo

PLACEBO COMPARATOR

Placebo Group

Drug: Placebo

Interventions

Aminolaevulinic acid (500-mg bottle) DRUG

once a week for 6 weeks

Also known as: ALA 500mg

ALA A Group

Aminolaevulinic acid (750-mg bottle) DRUG

once a week for 6 weeks

Also known as: ALA 750mg

ALA B Group

Placebo DRUG

once a week for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: May 31, 2021
• Primary Completion: December 20, 2023
• Study Completion: March 6, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

CN (5)