Gentium Announces Successful Completion of Defibrotide Phase 1 Study in Japan

Published on : Sunday, November 17, 2013

GentiumGentium 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
eastern Japan).

 
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.

 

Source:-Gentium S.p.A.

Tags: ,

Leave a Reply

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>

arrow2Follow TTW
 
facebook-logo  twitter-logo  LinkedIn_logo  stumbleupon-logo   rss_logo 
ttw_blogger_logo  ttw_blogger_logo  ttw_blogger_logo

ADVERTISEMENT

  • 02 wtm_london17
  • 04 AIME 2018
  • 12 indywood 17
  • 16 TT Warsaw 2017
  • 18 TTF17
  • 19 Emitt 18
  • 19 IITM
  • 43 PATA

TRAVEL INDUSTRY EVENTS

Get our toolbar!
Review www.travelandtourworld.com on alexa.com