A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
- Registration Number
- NCT03663114
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 713
Inclusion Criteria
- Participants with unresectable hepatocellular carcinoma who were administered the lenvatinib mesilate for the first time within the registration period.
- Have provided informed consent.
- Underwent case registration by 14 days after the start of administration of drug.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lenvatinib Lenvatinib Participants receiving lenvatinib capsules 12 milligrams (mg) based on participant's body weight greater than or equal to (\>=) 60 kilograms (kg) or 8 mg based on participant's body weight less than (\<) 60 kg, orally, once daily dose will be centrally registered and observed prospectively for up to 1 year after the administration of dose.
- Primary Outcome Measures
Name Time Method Number of Participants With Hepatic Encephalopathy Risk Factors Baseline up to 1 year Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed.
- Secondary Outcome Measures
Name Time Method Number of Participants with Hepatic Encephalopathy Baseline up to 1 year
Trial Locations
- Locations (2)
Eisai trial site 1
🇯🇵Osaka, Japan
Eisai trial site 2
🇯🇵Tokyo, Japan