Trial Condition(s):

Carcinoma, Hepatocellular

Nexavar post-marketing surveillance for hepatocellular carcinoma in Japan

Bayer Identifier:

15039

ClinicalTrials.gov Identifier:

NCT01411436

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Patients who received Nexavar for unresectable hepatocellular carcinoma
Exclusion Criteria
- Patients who are contraindicated based on the product label

Trial Summary

Enrollment Goal
1637
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Japan

Status
Completed
 

Trial Design