NCT01411436

Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,637 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Patients who have received Nexavar for unresectable HCC

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-03-01
• Completion: 2015-02-01
• First posted: 2011-08-08
• Last updated: 2015-03-04

Locations

1 site across 1 country: Japan