Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-11 @ 2:39 AM
Study NCT ID:
NCT04106258
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019339', 'term': 'Port-Wine Stain'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'week 8', 'description': 'proportion of patients achieving at least some improvement (color blanching from the baseline \\>= 20%)'}, {'measure': 'Incidence of adverse events and adverse reactions', 'timeFrame': 'up to 24 weeks after the treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Port-wine Stain']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with clinical diagnosis of PWS；\n* ≥2 years old and \\<7 years old；\n* The guardians agreed to voluntarily participate in this study and signed the informed consent agreement\n\nExclusion Criteria:\n\n* Therapy area located outside of head and neck;\n* Other skin diseases that might interfere with the efficacy evaluation;\n* Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;\n* Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;\n* with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;\n* Cicatricial constitution;\n* Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;\n* Electrocardiographic abnormalities or organic heart diseases;\n* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \\> 1.5 upper limit of normal \\[ULN\\], or serum creatinine or blood urea nitrogen \\> 1.5 ULN);\n* Coagulation disorders;\n* Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;\n* Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia；\n* Previous therapy of PWS within the last 4 weeks;\n* Participation in any clinical studies within the last 4 weeks;\n* Be judged not suitable to participate the study by the investigators'}, 'identificationModule': {'nctId': 'NCT04106258', 'briefTitle': 'A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain', 'orgStudyIdInfo': {'id': 'HMME-C1904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low light dose', 'description': 'PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes', 'interventionNames': ['Drug: Hemoporfin PDT']}, {'type': 'EXPERIMENTAL', 'label': 'high light dose', 'description': 'PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes', 'interventionNames': ['Drug: Hemoporfin PDT']}], 'interventions': [{'name': 'Hemoporfin PDT', 'type': 'DRUG', 'description': 'Photodynamic therapy is performed using hemoporfin under general anesthesia. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.', 'armGroupLabels': ['high light dose', 'low light dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}