A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
A Drug Use Investigation of LENVIMA 4 mg Capsules - A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Patients With Unresectable Hepatocellular Carcinoma
2 other identifiers
observational
713
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2018
CompletedFirst Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedJanuary 22, 2021
January 1, 2020
1.6 years
September 6, 2018
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Hepatic Encephalopathy Risk Factors
Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed.
Baseline up to 1 year
Secondary Outcomes (1)
Number of Participants with Hepatic Encephalopathy
Baseline up to 1 year
Study Arms (1)
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.
Interventions
Eligibility Criteria
All participants with unresectable hepatocellular carcinoma and administered lenvatinib in Japan will be observed prospectively.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (2)
Eisai trial site 1
Osaka, Japan
Eisai trial site 2
Tokyo, Japan
Related Publications (1)
Furuse J, Izumi N, Motomura K, Inaba Y, Katamura Y, Kondo Y, Yabushita K, Matsuoka T, Motoyoshi K, Kudo M. Long-Term Survival of Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib in Real-World Clinical Practice. Cancers (Basel). 2025 Feb 1;17(3):479. doi: 10.3390/cancers17030479.
PMID: 39941845DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2018
First Posted
September 10, 2018
Study Start
July 2, 2018
Primary Completion
February 20, 2020
Study Completion
February 20, 2020
Last Updated
January 22, 2021
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.