Project Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
Funding Agency:
Johnson & Johnson
Project Status:
open to enrollment
Principal Investigator:
Juan Puyana, MD
Project Summary:
The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo.
Secondary objectives will include a comparison of epoetin alfa-dosed subjects and placebo subjects with regard to the following endpoints: cumulative number of units of RBC transfusions received from Study Day 1 through Study Day 42, change in hemoglobin (Hgb) from Study Day 1 through Study Day 29, mortality through Study Day 29 and cumulative mortality through Study Day 140.
Safety objectives include assessment of the tolerability and safety of a 40,000 IU once a week dosing regimen, with particular attention being paid to longer-term clinical and laboratory safety follow-up after Study Day 29. In addition, the incidence of antierythropoietin antibodies at baseline and at Study Day 42 will be determined for subjects exposed to study drug.
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