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Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

NCT01411436 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1637

Last updated 2015-03-04

No results posted yet for this study

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

DRUG

Sorafenib (Nexavar, BAY43-9006)

Patients who have received Nexavar for unresectable HCC

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2014-03-31
Completion
2015-02-28

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01411436 on ClinicalTrials.gov