Overview

This trial is active, not recruiting.

Conditions cervical persistent high risk hpv infection, cervical intraepithelial neoplasia
Treatment aminolaevulinic acid photodynamic therapy
Phase phase 2
Sponsor Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
Start date December 2014
End date November 2016
Trial size 73 participants
Trial identifier NCT02304770, FDZJALA-201409

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection
aminolaevulinic acid photodynamic therapy
Aminolaevulinic acid mediated photodynamic therapy
(Experimental)
Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection
aminolaevulinic acid photodynamic therapy
Aminolaevulinic acid mediated photodynamic therapy
(Experimental)
Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3
aminolaevulinic acid photodynamic therapy
Aminolaevulinic acid mediated photodynamic therapy

Primary Outcomes

Measure
Response Rate
time frame: 3 months after treatments
clearance of high risk HPV
time frame: 3 months after treatments

Eligibility Criteria

Female participants from 25 years up to 50 years old.

Inclusion Criteria: 1. Premenopausal women, 25-50 years of age 2. 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 3. Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative 4. 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 5. 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 6. Written informed consent signed Exclusion Criteria: 1. 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 2. Invasive carcinoma possibility or positive endocervical curettage on colposcopy 3. Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination 4. Undiagnosed vaginal bleeding 5. With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds 6. Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases 7. Pregnancy or nursing 8. Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study 9. Participation in any clinical studies within the last 30 days 10. Subjects that the investigators judged to be not suitable to participate the study besides above

Additional Information

Official title A Pilot Study of Aminolaevulinic Acid (ALA) Photodynamic Therapy (PDT) in Patients With Cervical Persistent High Risk HPV Infection or Cervical Intraepithelial Neoplasia
Principal investigator Beihua Kong, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd..