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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663114
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief 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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Lenvatinib

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Study Type : Observational
Actual Enrollment : 713 participants
Observational Model: Other
Time Perspective: Prospective
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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Group/Cohort Intervention/treatment
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.
Drug: Lenvatinib
Lenvatinib capsule
Other Names:
  • Lenvima
  • E7080




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Participants with Hepatic Encephalopathy [ Time Frame: Baseline up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants with unresectable hepatocellular carcinoma and administered lenvatinib in Japan will be observed prospectively.
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.

Information from the National Library of Medicine

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


Locations
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Japan
Eisai trial site 1
Osaka, Japan
Eisai trial site 2
Tokyo, Japan
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03663114    
Other Study ID Numbers: LEN02T
E7080-M081-504 ( Other Identifier: EISAI )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Keywords provided by Eisai Inc.:
Hepatocellular Carcinoma
Lenvima
Post-marketing surveillance
LEN02T
Lenvatinib Mesilate
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Hepatic Encephalopathy
Brain Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action