Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 4:42 PM
Study NCT ID:
NCT06439433
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Response rate of HPV16 and/or HPV18 positive patients at week 12 after last treatment', 'timeFrame': 'Baseline and week 12 after treatments', 'description': '"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1'}, {'measure': 'Response rate of HPV16 and/or HPV18 positive patients at week 24 after last treatment', 'timeFrame': 'Baseline and week 24 after treatments', 'description': '"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1'}], 'primaryOutcomes': [{'measure': 'Response rate at week 12 after last treatment', 'timeFrame': 'Baseline and week 12 after treatments', 'description': '"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1'}], 'secondaryOutcomes': [{'measure': 'Response rate at week 24 after last treatment', 'timeFrame': 'Baseline and week 24 after treatments', 'description': '"Response" is defined as: pathology showed normal or only inflammatory changes or CIN1'}, {'measure': 'Cure rate at week 12 after last treatment', 'timeFrame': 'Baseline and week 12 after treatments', 'description': '"Cure" is defined as: pathology showed normal or only inflammatory changes'}, {'measure': 'Cure response rate at week 24 after last treatment', 'timeFrame': 'Baseline and week 24 after treatments', 'description': '"Cure" is defined as: pathology showed normal or only inflammatory changes'}, {'measure': 'Clearance rate of HPV at week 12 after last treatment', 'timeFrame': 'Baseline and week 12 after treatments', 'description': 'Proportion of patients with HPV clearance'}, {'measure': 'Clearance rate of HPV at week 24 after last treatment', 'timeFrame': 'Baseline and week 24 after treatments', 'description': 'Proportion of patients with HPV clearance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Intraepithelial Neoplasia Grade 2', 'Papillomavirus Infections', 'p16 Protein']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women, 18-45 years of age\n* 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\n* Intense desire to retain the cervical structure or function\n* 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\n* 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\n* Signed written informed consent\n\nExclusion Criteria:\n\n* 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\n* Invasive carcinoma possibility or lesions extending to the vaginal wall\n* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination\n* Undiagnosed vaginal bleeding within the last 3 months\n* With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues\n* 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\n* 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)\n* History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months\n* Pregnancy or nursing\n* Participation in any clinical studies within the last 30 days\n* Poor compliance or inability to complete the trial\n* Subjects that the investigators judged to be not suitable to participate the study besides above'}, 'identificationModule': {'nctId': 'NCT06439433', 'briefTitle': 'ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FDZJYX-ALA-202001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALA A Group', 'description': 'ALA 500mg Group', 'interventionNames': ['Drug: Aminolaevulinic acid (500-mg bottle)']}, {'type': 'EXPERIMENTAL', 'label': 'ALA B Group', 'description': 'ALA 750mg Group', 'interventionNames': ['Drug: Aminolaevulinic acid (750-mg bottle)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aminolaevulinic acid (500-mg bottle)', 'type': 'DRUG', 'otherNames': ['ALA 500mg'], 'description': 'once a week for 6 weeks', 'armGroupLabels': ['ALA A Group']}, {'name': 'Aminolaevulinic acid (750-mg bottle)', 'type': 'DRUG', 'otherNames': ['ALA 750mg'], 'description': 'once a week for 6 weeks', 'armGroupLabels': ['ALA B Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once a week for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'The Obstetrics & Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}