Trials & Filings

Gentium’s DF Passes Phase I in Japan

Safety, PK test successful

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Phase I trial of Gentium’s Defibrotide (DF) was completed by the Translational Research Center at the National University Corporation, Hamamatsu University School of Medicine (“HUSM”), Fukushima Medical University (“FMU”) in 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 sys...

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