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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03663114

Enrollment

713

Registered

2018-09-10

Start date

2018-07-02

Completion date

2020-02-20

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Carcinoma, Lenvima, Post-marketing surveillance, LEN02T, Lenvatinib Mesilate

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.

Interventions

DRUGLenvatinib

Lenvatinib capsule

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Number of Participants with Hepatic Encephalopathy	Baseline up to 1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026