Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

Bayer

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01411436

NEXAVAR-HCC-01 (Other Identifier)

15039

Details and patient eligibility

About

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.

Enrollment: 1,637 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

1,637 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)