G-CSF in the Treatment of Toxic Epidermal Necrolysis (NeupoNET)
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|ClinicalTrials.gov Identifier: NCT02739295|
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : April 22, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|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|
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%
- 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
- 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)
- Biological data: Neutrophilic count [ Time Frame: Every day during the 14th first days ]Neutrophilic count
- Biological data: WBC count [ Time Frame: 3 months after discharge ]WBC count
- Biological data: WBC formula [ Time Frame: 3 months after discharge ]WBC formula
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
|Contact: Anne-Françoise Rousseau, MD, PhDfirstname.lastname@example.org|