G-CSF in the Treatment of Toxic Epidermal Necrolysis (NeupoNET)

University of Liege

Status and phase: Completed; Phase 4

Conditions: Stevens - Johnson Syndrome

Treatments: Drug: recombinant granulocyte - colony stimulating factor; Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT02739295

L002

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

G-CSF

Experimental group

Description:

An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.

Treatment:

Drug: recombinant granulocyte - colony stimulating factor

Placebo

Placebo Comparator group

Description:

An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.

Treatment:

Drug: NaCl 0.9%