A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai trial site 1, Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lenvatinib

Drug

Lenvatinib capsule

Other names: Lenvima, E7080

Primary outcomes

Number of Participants With Hepatic Encephalopathy Risk Factors

Time frame: Baseline up to 1 year

Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed.

Secondary outcomes

Number of Participants with Hepatic Encephalopathy

Time frame: Baseline up to 1 year

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Sep 10, 2018
Registry last updated: Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed