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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04008082
Other study ID # E7080-M081-510
Secondary ID LEN03T
Status Completed
Phase
First received
Last updated
Start date May 14, 2019
Est. completion date January 28, 2022

Study information

Verified date June 2021
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary purpose of this study to continue follow-up of participants enrolled in the study E7080-M081-504 (NCT03663114) of lenvima capsules and to evaluate the overall survival of participants with hepatocellular carcinoma.


Recruitment information / eligibility

Status Completed
Enrollment 412
Est. completion date January 28, 2022
Est. primary completion date January 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study. Exclusion Criteria: - Participants who do not have unresectable hepatocellular carcinoma - Participants who have not given informed consent or have withdrawn consent to participation - Participants with a history of hypersensitivity to any ingredient of lenvima - Pregnant or possibly pregnant women - Participants previously treated with lenvima (excluding those previously enrolled in the Study E7080-M081-504 [NCT03663114] at another clinical site).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenvatinib
Lenvatinib capsule.

Locations

Country Name City State
Japan Eisai Trial Site #1 Osaka
Japan Eisai Trial Site #2 Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) OS is calculated as the period from the day of starting administration to the day of death from any cause. From date of study drug administration until date of death from any cause (approximately 2.8 years)
Primary Presence or absence of factors with a possible influence on OS Factor analysis is performed according to the category of participant background (aetiology of chronic liver disease, baseline alpha-fetoprotein concentration etc), lenvima administration status and treatment situation before and after administration of lenvima, and factors affecting OS are examined. Appropriate statistical methods (Cox regression analysis, etc.) will be used to examine the relationship of OS with various factors in order to identify the factors affecting survival. From date of study drug administration until date of death from any cause (approximately 2.8 years)
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