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Clinical trial

Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis

ID
Name
L002
Description
NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial. Patients 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.
Trial arms
Trial start
2016-07-01
Estimated PCD
2023-03-07
Trial end
2023-03-07
Status
Completed
Phase
Early phase I
Treatment
recombinant granulocyte - colony stimulating factor
Arms:
G-CSF
Other names:
Neupogen (Amgen)
NaCl 0.9%
Arms:
Placebo
Size
10
Primary endpoint
Time for healing
From date of randomization until the date of complete healing, assessed up to 30 days.
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
At admission and at day 5
Biological data: Neutrophilic count
Every day during the 14th first days
Eligibility criteria
Inclusion Criteria: * Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission Exclusion Criteria: * Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission * Hypercoagulable state * Cardiac or peripheral arterial disease * Active malignancy * Myelodysplastic syndrome or hematological malignancy * Fructose intolerance * Pregnancy * Patient refusal
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2023-06-27

1 organization

1 product

1 drug

1 indication

Organization
University of Liege
Product
Recombinant granulocyte-colony stimulating factor
Indication
Stevens-Johnson Syndrome
Drug
Varlilumab