A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT03663114|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : July 31, 2020
|Condition or disease||Intervention/treatment|
|Carcinoma, Hepatocellular||Drug: Lenvatinib|
|Study Type :||Observational|
|Actual Enrollment :||713 participants|
|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|
|Actual Study Start Date :||July 2, 2018|
|Actual Primary Completion Date :||February 26, 2020|
|Estimated Study Completion Date :||May 2021|
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.
- 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.
- Number of Participants with Hepatic Encephalopathy [ Time Frame: Baseline up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663114
|Eisai trial site 1|
|Eisai trial site 2|