CompletedPhase 4

G-CSF in the Treatment of Toxic Epidermal Necrolysis

Belgium10 participantsStarted 2016-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time for healing

Timeframe: 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)

Timeframe: At admission and at day 5

Biological data: Neutrophilic count

Timeframe: Every day during the 14th first days

Trial details

NCT IDNCT02739295

SponsorUniversity of Liege

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-07

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