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Published on : Sunday, November 17, 2013
Gentium S.p.A. today announced that the medical team from the Phase 1 Trial Unit of the Translational Research Center at the National University Corporation, Hamamatsu University School of Medicine (“HUSM”), Fukushima Medical University (“FMU) has successfully completed the phase 1 clinical study to evaluate the Safety and Pharmacokinetics of Defibrotide (DF) in Healthy Adults.
This Investigator led clinical trial was adopted as a Health and Labour Sciences Research
Grant in 2012 for Practical Use of Medical Technology (categorized as a study project to
support practical drug/medical device use during the reconstruction of disaster-hit areas in
The primary objective of the study was to evaluate the safety and pharmacokinetics of
defibrotide in healthy Japanese adult subjects. The secondary objective was to evaluate the
effect of defibrotide on the coagulation and fibrinolytic systems in vivo. Two dose levels (3
mg/kg and 6.25 mg/kg, termed Cohort 1 and Cohort 2, respectively) were evaluated, each
cohort consisted of 10 subjects (8 subjects were given DF, 2 were given placebo).
All 20 subjects completed the protocol defined treatment and there were no premature
discontinuations. No serious adverse events were noted and only one mild, transient and
reversible adverse event observed. Moreover, no clinically significant changes were observed in laboratory test results in any of the dosing groups.