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

Eisai

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Lenvatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03663114

E7080-M081-504 (Other Identifier)

LEN02T

Details and patient eligibility

About

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.

Enrollment: 713 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.
• Underwent case registration by 14 days after the start of administration of drug.

Trial design

713 participants in 1 patient group

Lenvatinib

Description:

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.

Treatment:

Drug: Lenvatinib