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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02739295
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rousseau, University of Liege

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.


Condition or disease Intervention/treatment Phase
Stevens - Johnson Syndrome Drug: recombinant granulocyte - colony stimulating factor Drug: NaCl 0.9% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
Study Start Date : July 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Experimental: G-CSF
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
Other Name: Neupogen (Amgen)

Placebo Comparator: Placebo
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%



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739295


Contacts
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Contact: Anne-Françoise Rousseau, MD, PhD afrousseau@chu.ulg.ac.be

Locations
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Belgium
Burn Centre of the University Hospital of Liège Recruiting
Liège, Belgium, 4000
Contact: Anne-Françoise Rousseau, MD, PhD       afrousseau@chu.ulg.ac.be   
IMTR Burn Centre Recruiting
Loverval, Belgium
Contact: Serge Jennes       sergejennes@hotmail.com   
Sponsors and Collaborators
University of Liege

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Responsible Party: Rousseau, MD, PhD, University of Liege
ClinicalTrials.gov Identifier: NCT02739295    
Other Study ID Numbers: L002
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stevens-Johnson Syndrome
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Sargramostim
Immunologic Factors
Physiological Effects of Drugs