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| ID | Type | Description | Link |
|---|---|---|---|
| E7080-M081-504 | Other Identifier | EISAI |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Hepatic Encephalopathy | Baseline up to 1 year |
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Inclusion Criteria:
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All participants with unresectable hepatocellular carcinoma and administered lenvatinib in Japan will be observed prospectively.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai trial site 1 | Osaka | Japan | ||||
| Eisai trial site 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39941845 | Derived | Furuse J, Izumi N, Motomura K, Inaba Y, Katamura Y, Kondo Y, Yabushita K, Matsuoka T, Motoyoshi K, Kudo M. Long-Term Survival of Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib in Real-World Clinical Practice. Cancers (Basel). 2025 Feb 1;17(3):479. doi: 10.3390/cancers17030479. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| Tokyo |
| Japan |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |