Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received Nexavar for unresectable
hepatocellular carcinoma (HCC). The objective of this study is to assess safety and
effectiveness of Nexavar under real-life practice conditions. This study is an all case
investigation of which the enrollment period is 2 or 3 months (dependent on sites) for
Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with
Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be
recruited and followed one year since starting Nexavar administration.