G-CSF in the Treatment of Toxic Epidermal Necrolysis

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Toxic Epidermal Necrolysis
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Brief Title

G-CSF in the Treatment of Toxic Epidermal Necrolysis

Official Title

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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Time for healing

Secondary Outcome

 Biological data: WBC count

Condition

Stevens - Johnson Syndrome

Intervention

recombinant granulocyte - colony stimulating factor

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

10

Start Date

July 2016

Completion Date

July 2022

Primary Completion Date

July 2022

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT02739295

Organization ID

L002

Responsible Party

Principal Investigator

Study Sponsor

University of Liege

Study Sponsor

, ,

Verification Date

November 2020