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 (Study LEN02T)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080224665

Enrollment

500

Registered

2019-05-07

Start date

2019-05-08

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Unresectable Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : Lenvima Capsule 4 mg INN of investigational material : Lenvatinib Mesilate Therapeutic category code : 429 Other antitumor agents Dosage and Administrati

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1)Patients with a history of hypersensitivity to components of Lenvima Capsule 2)Female patients who is pregnant or may be pregnant 3)Patients with a history of administration of this drug (except for patients who have been registered for this study at other facilities in the past)

Design outcomes

Primary

Measure	Time frame
safety Number of Participants With Hepatic Encephalopathy Risk Factors Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed.	—

Secondary

Measure	Time frame
safety Number of Participants with Hepatic Encephalopathy	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026