G-CSF in the Treatment of Toxic Epidermal Necrolysis

NCT02739295 | Completed Phase 4

• 1 other identifier: L002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stevens - Johnson Syndrome

Outcome Measures

Primary Outcomes (3)

• Time for healing

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

  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)

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

  At admission and at day 5

• Biological data: Neutrophilic count

  Neutrophilic count

  Every day during the 14th first days

Secondary Outcomes (2)

• Biological data: WBC count

  3 months after discharge

• Biological data: WBC formula

  3 months after discharge

Study Arms (2)

G-CSF

EXPERIMENTAL

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

Drug: recombinant granulocyte - colony stimulating factor

Placebo

PLACEBO COMPARATOR

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

Drug: NaCl 0.9%

Interventions

recombinant granulocyte - colony stimulating factor DRUG

Also known as: Neupogen (Amgen)

G-CSF

NaCl 0.9% DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (2)

Burn Centre of the University Hospital of Liège

Liège, 4000, Belgium

Location

IMTR Burn Centre

Loverval, Belgium

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Filgrastim; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 15, 2016
• Study Start: July 1, 2016
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: December 31, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)