Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-04-22 @ 4:51 PM
Study NCT ID:
NCT03125057
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2017-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Hemoporfin PDT in Children 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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', '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%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Port-wine Stain']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with clinical diagnosis of PWS；\n* Age range: 7 to 14 years-old；\n* Voluntarily participated and Written informed consent signed\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* Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;\n* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;\n* Scar diathesis;\n* Immunocompromised conditions;\n* Electrocardiographic abnormalities or organic heart diseases;\n* Coagulation disorders;\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* Psychiatric diseases; Severe endocrinopathies;\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': 'NCT03125057', 'briefTitle': 'A Pilot Study of Hemoporfin PDT in Children 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 (7-14 Years Old) With Port-wine Stain', 'orgStudyIdInfo': {'id': 'HMME-C1610'}}, '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. 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': '100045', 'city': 'Beijing', 'country': 'China', 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Lin Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bejing Children's Hospital, Capital Medical University"}, {'name': 'Jining Tao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}