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NCT03663114 Clinical Trial

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

Carcinoma, Hepatocellular Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03663114
Other study ID # LEN02T
Secondary ID E7080-M081-504
Status Completed
Phase
First received
Last updated
Start date July 2, 2018
Est. completion date February 20, 2020

Study information
Verified date January 2020
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 713
Est. completion date February 20, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lenvatinib
Lenvatinib capsule

Locations
Country Name City State
Japan Eisai trial site 1 Osaka
Japan Eisai trial site 2 Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of Participants with Hepatic Encephalopathy Baseline up to 1 year
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