Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia

NCT02304770 | Completed Phase 2

• 1 other identifier: FDZJALA-201409
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.

Conditions

Cervical Persistent High Risk HPV Infection; Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (2)

• Response Rate

  Based on histology

  3 months after treatments

• clearance of high risk HPV

  proportion of patients with high risk HPV clearance

  3 months after treatments

Study Arms (3)

cervical persistent high risk HPV infection

EXPERIMENTAL

Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection

Drug: Aminolaevulinic acid photodynamic therapy

CIN 1 with high risk HPV infection

EXPERIMENTAL

Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection

Drug: Aminolaevulinic acid photodynamic therapy

CIN 2/3

EXPERIMENTAL

Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3

Drug: Aminolaevulinic acid photodynamic therapy

Interventions

Aminolaevulinic acid photodynamic therapy DRUG

Aminolaevulinic acid mediated photodynamic therapy

CIN 1 with high risk HPV infection; CIN 2/3; cervical persistent high risk HPV infection

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women, 25-50 years of age
• Meet one of the 3 following conditions:
• high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function
• Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
• In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
• 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
• Written informed consent signed

You may not qualify if:

• Atypical glandular cells of undetermined significance (AGUS) 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 positive endocervical curettage on colposcopy
• Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
• Undiagnosed vaginal bleeding
• With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds
• Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases
• Pregnancy or nursing
• Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study
• Participation in any clinical studies within the last 30 days
• 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 (4)

The First Affliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210036, 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

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Beihua Kong, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Youzhong Zhang, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Jining Tao, Master

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

CN (4)