Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
FDA Office of Orphan Products Development
Phase 1/Phase 2
The purpose of this study is to determine the effects of etanercept, and define the
toxicity, when administered to patients with acute non-infectious lung injury (idiopathic
pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell
6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome
Background: Systemic corticosteroids are considered in patients with an adverse clinical
course suffering from conditions like the acute respiratory distress syndrome (ARDS) and
septic shock. Treated patients not only show improved respiratory function, but also
hemodynamic status and overall multiple organ dysfunction score.
Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical
course of multiple organ dysfunction syndrome (MODS).
Design: Multi-center, double-blind, randomized, placebo-controlled.
Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous
solution). The duration of the study medication administration protocol is 32 days (1).
1. All cause Intensive Care Unit (ICU) and 28-day mortality
2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.
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