G-CSF in the Treatment of Toxic Epidermal Necrolysis

Stevens - Johnson Syndrome Clinical Trial

— NeupoNET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739295
• Other study ID #: L002
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: March 7, 2023

Study information

• Verified date: June 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stevens - Johnson Syndrome
• Stevens-Johnson Syndrome

Intervention

Drug:
• recombinant granulocyte - colony stimulating factor

• NaCl 0.9%

Locations

Country	Name	City	State
Belgium	Burn Centre of the University Hospital of Liège	Liège
Belgium	IMTR Burn Centre	Loverval

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	Biological data: Neutrophilic count	Neutrophilic count	Every day during the 14th first days
Secondary	Biological data: WBC count	WBC count	3 months after discharge
Secondary	Biological data: WBC formula	WBC formula	3 months after discharge