Severe Bullous Drug Eruption and Filgrastim

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 13, 2022

Primary Completion Date

May 18, 2025

Study Completion Date

May 13, 2026

Conditions
Rare DiseasesToxic Epidermal Necrolyses
Interventions
DRUG

Filgrastim

"Injection of ZARZIO 30 MU/0,5mL and/or ZARZIO 48 MU/0,5mL, over a period of 5 consecutive days (1 injection per day during 30 minutes - - day 1 : set up standard treatment). The filgrastim solution will be diluted in 20 mL of 5% Glucose. The dose of ZARZIO administrated depends of the patient's weight :~* 20 to \< 30kg = 0,3 mL of ZARZIO 48 MU/0,5mL (subcutaneous route)~* 30 to \< 60kg = 0,5 mL of ZARZIO 30 MU/0,5mL (by IV)~* 60 to \< 90kg = 0,5 mL of ZARZIO 48 MU/0,5mL (by IV)~* 90 to \< 120kg = 2x0,5 mL of ZARZIO 30 MU/0,5mL (by IV)~* 120 to 150kg = 0,5 mL of ZARZIO 30 MU/0,5mL + 0,5 mL of ZARZIO 48 MU/0,5mL (by IV)~* \> 150kg = 2x0,5 mL of ZARZIO 48 MU/0,5mL (by IV)"

DRUG

Placebo

"Injection of 20 mL of Glucose 5% solution over a period of 5 consecutive days (1 injection per day during 30 minutes - day 1 : set up standard treatment). The dose given is equivalent to that used for filgrastim :~* 20 to \< 30kg = placebo not available because the injection must be done subcutaneously so the blind cannot be respected.~* 30 to \< 60kg = 20mL of Glucose 5% solution (by IV)~* 60 to \< 90kg = 20mL of Glucose 5% solution (by IV)~* 90 to \< 120kg = 20mL of Glucose 5% solution (by IV)~* 120 to 150kg = 20mL of Glucose 5% solution (by IV)~* \> 150kg = 20mL of Glucose 5% solution (by IV)"

Trial Locations (3)

69437

RECRUITING

Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon

RECRUITING

Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon

RECRUITING

Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER