This is a study designed to assess the safety of administration of up to 3 dose levels of eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant (BMT). An allogeneic BMT is the transplantation of blood stem cells taken from the bone marrow or blood of another person.
Please note: in the original protocol, the study phase is listed as "Phase Ib", although the Official Title reads "Phase I".
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Three dose levels of Eritoran IV over 14 days for a total of 32, 96, and 224 mg over 14 days.
Case Western Reserve University School of Medicine
Cleveland, Ohio, United States
Safety and assessments will be done daily.
Time frame: Performed daily through Day 28, with follow-up every other week to Day 100 and at 1 year post-transplant.
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