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

Primary Purpose

Stevens - Johnson Syndrome

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
recombinant granulocyte - colony stimulating factor
NaCl 0.9%
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stevens - Johnson Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Burn Centre of the University Hospital of Liège
  • IMTR Burn Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G-CSF

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time for healing
Time for complete cutaneous healing, considered as healing of 90% of the body surface area
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Biological data: Neutrophilic count
Neutrophilic count

Secondary Outcome Measures

Biological data: WBC count
WBC count
Biological data: WBC formula
WBC formula

Full Information

First Posted
April 4, 2016
Last Updated
June 25, 2023
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT02739295
Brief Title
G-CSF in the Treatment of Toxic Epidermal Necrolysis
Acronym
NeupoNET
Official Title
Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stevens - Johnson Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-CSF
Arm Type
Experimental
Arm Description
An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.
Intervention Type
Drug
Intervention Name(s)
recombinant granulocyte - colony stimulating factor
Other Intervention Name(s)
Neupogen (Amgen)
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Primary Outcome Measure Information:
Title
Time for healing
Description
Time for complete cutaneous healing, considered as healing of 90% of the body surface area
Time Frame
From date of randomization until the date of complete healing, assessed up to 30 days.
Title
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Description
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Time Frame
At admission and at day 5
Title
Biological data: Neutrophilic count
Description
Neutrophilic count
Time Frame
Every day during the 14th first days
Secondary Outcome Measure Information:
Title
Biological data: WBC count
Description
WBC count
Time Frame
3 months after discharge
Title
Biological data: WBC formula
Description
WBC formula
Time Frame
3 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Burn Centre of the University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
IMTR Burn Centre
City
Loverval
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

G-CSF in the Treatment of Toxic Epidermal Necrolysis

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