Spots Global Cancer Trial Database for Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
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Trial Identification
Brief Title: Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
Official Title: Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)
Study ID: NCT01411436
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Many locations, , Japan
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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