Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-04-15 @ 10:58 PM
Study NCT ID:
NCT02739295
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2016-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
G-CSF in the Treatment of Toxic Epidermal Necrolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013262', 'term': 'Stevens-Johnson Syndrome'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004892', 'term': 'Erythema Multiforme'}, {'id': 'D004890', 'term': 'Erythema'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for healing', 'timeFrame': 'From date of randomization until the date of complete healing, assessed up to 30 days.', 'description': 'Time for complete cutaneous healing, considered as healing of 90% of the body surface area'}, {'measure': 'Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)', 'timeFrame': 'At admission and at day 5', 'description': 'Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)'}, {'measure': 'Biological data: Neutrophilic count', 'timeFrame': 'Every day during the 14th first days', 'description': 'Neutrophilic count'}], 'secondaryOutcomes': [{'measure': 'Biological data: WBC count', 'timeFrame': '3 months after discharge', 'description': 'WBC count'}, {'measure': 'Biological data: WBC formula', 'timeFrame': '3 months after discharge', 'description': 'WBC formula'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stevens - Johnson Syndrome']}, 'descriptionModule': {'briefSummary': 'NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.\n\nPatients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission\n\nExclusion Criteria:\n\n* Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission\n* Hypercoagulable state\n* Cardiac or peripheral arterial disease\n* Active malignancy\n* Myelodysplastic syndrome or hematological malignancy\n* Fructose intolerance\n* Pregnancy\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02739295', 'acronym': 'NeupoNET', 'briefTitle': 'G-CSF in the Treatment of Toxic Epidermal Necrolysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis', 'orgStudyIdInfo': {'id': 'L002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-CSF', 'description': 'An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.', 'interventionNames': ['Drug: recombinant granulocyte - colony stimulating factor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.', 'interventionNames': ['Drug: NaCl 0.9%']}], 'interventions': [{'name': 'recombinant granulocyte - colony stimulating factor', 'type': 'DRUG', 'otherNames': ['Neupogen (Amgen)'], 'armGroupLabels': ['G-CSF']}, {'name': 'NaCl 0.9%', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Burn Centre of the University Hospital of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Loverval', 'country': 'Belgium', 'facility': 'IMTR Burn Centre', 'geoPoint': {'lat': 50.37519, 'lon': 4.47332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anne-Françoise Rousseau', 'investigatorAffiliation': 'University of Liege'}}}}