G-CSF in the Treatment of Toxic Epidermal Necrolysis

NCT ID: NCT02739295

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2023-03-07

Brief Summary

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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.

Detailed Description

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Conditions

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Stevens - Johnson Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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G-CSF

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

Group Type EXPERIMENTAL

recombinant granulocyte - colony stimulating factor

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

Interventions

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recombinant granulocyte - colony stimulating factor

Intervention Type DRUG

NaCl 0.9%

Intervention Type DRUG

Other Intervention Names

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Neupogen (Amgen)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Anne-Françoise Rousseau

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Burn Centre of the University Hospital of Liège

Liège, , Belgium

Site Status

IMTR Burn Centre

Loverval, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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L002

Identifier Type: -

Identifier Source: org_study_id