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

May 28, 2024 updated by: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Group
Drug: Placebo
once a week for 6 weeks
Experimental: ALA A Group
ALA 500mg Group
Drug: Aminolaevulinic acid (500-mg bottle)
once a week for 6 weeks
Other Names:
  • ALA 500mg
Experimental: ALA B Group
ALA 750mg Group
Drug: Aminolaevulinic acid (750-mg bottle)
once a week for 6 weeks
Other Names:
  • ALA 750mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

March 6, 2024

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZJYX-ALA-202001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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