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Completed

NCT Number: NCT02739295

G-CSF in the Treatment of Toxic Epidermal Necrolysis

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.

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Key information

Conditions

Stevens - Johnson Syndrome Chemically-Induced Disorders Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Erythema Erythema Multiforme Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Mouth Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stevens-Johnson Syndrome Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Burn Centre of the University Hospital of Liège, Liège, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant granulocyte - colony stimulating factor

Drug

Other names: Neupogen (Amgen)

NaCl 0.9%

Drug

Primary outcomes

  1. Time for healing

    Time frame: From date of randomization until the date of complete healing, assessed up to 30 days.

    Time for complete cutaneous healing, considered as healing of 90% of the body surface area

  2. Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)

    Time frame: At admission and at day 5

    Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)

  3. Biological data: Neutrophilic count

    Time frame: Every day during the 14th first days

    Neutrophilic count

Secondary outcomes

  1. Biological data: WBC count

    Time frame: 3 months after discharge

    WBC count

  2. Biological data: WBC formula

    Time frame: 3 months after discharge

    WBC formula

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Acronym: NeupoNET

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2016
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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