- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05225207
A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants
January 6, 2023 updated by: Eisai Korea Inc.
A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
The purpose of this study is to describe the following safety and the efficacy of Lenvima for the first-line treatment indication of participants with uHHC in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the precautions for use (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
658
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of
- Site #31
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Busan, Korea, Republic of
- Site #39
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Busan, Korea, Republic of
- Site #40
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Daegu, Korea, Republic of
- Site #17
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Daegu, Korea, Republic of
- Site #18
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Daegu, Korea, Republic of
- Site #26
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Daegu, Korea, Republic of
- Site #30
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Daegu, Korea, Republic of
- Site #41
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Daejeon, Korea, Republic of
- Site #19
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Daejeon, Korea, Republic of
- Site #20
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Daejeon, Korea, Republic of
- Site #24
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Daejeon, Korea, Republic of
- Site #34
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Incheon, Korea, Republic of
- Site #21
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Incheon, Korea, Republic of
- Site #33
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Incheon, Korea, Republic of
- Site #36
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Seoul, Korea, Republic of
- Site #01
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Seoul, Korea, Republic of
- Site #02
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Seoul, Korea, Republic of
- Site #04
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Seoul, Korea, Republic of
- Site #07
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Seoul, Korea, Republic of
- Site #08
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Seoul, Korea, Republic of
- Site #09
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Seoul, Korea, Republic of
- Site #10
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Seoul, Korea, Republic of
- Site #12
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Seoul, Korea, Republic of
- Site #16
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Seoul, Korea, Republic of
- Site #22
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Seoul, Korea, Republic of
- Site #23
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Seoul, Korea, Republic of
- Site #25
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Seoul, Korea, Republic of
- Site #42
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Seoul, Korea, Republic of
- Site #43
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Seoul, Korea, Republic of
- Site #44
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Ulsan, Korea, Republic of
- Site #11
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Chungcheongnam-do
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Cheonan, Chungcheongnam-do, Korea, Republic of
- Site #32
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Gyeonggi-do
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Bucheon, Gyeonggi-do, Korea, Republic of
- Site #35
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Bucheon, Gyeonggi-do, Korea, Republic of
- Site #38
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Goyang, Gyeonggi-do, Korea, Republic of
- Site #06
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Seongnam, Gyeonggi-do, Korea, Republic of
- Site #03
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Suwon, Gyeonggi-do, Korea, Republic of
- Site #13
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Suwon, Gyeonggi-do, Korea, Republic of
- Site #27
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Uijeongbu, Gyeonggi-do, Korea, Republic of
- Site #15
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Gyeongsangnam-do
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Changwon, Gyeongsangnam-do, Korea, Republic of
- Site #37
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Yangsan, Gyeongsangnam-do, Korea, Republic of
- Site #28
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Yangsan, Gyeongsangnam-do, Korea, Republic of
- Site #29
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with uHHC administered with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator.
Description
Inclusion Criteria:
- Participants over 18 years
- Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea
- Participants who have given their consent to study participation about the use of the personal data and medical data
Exclusion Criteria:
- Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
- Participants who are pregnant or breastfeeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All Participants
Participants with uHCC who are prescribed with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator will be enrolled and observed for up to 12 months.
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No intervention will be administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From first dose of study drug up to 12 months
|
A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.
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From first dose of study drug up to 12 months
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Number of Participants With Serious Adverse Drug Reactions (ADRs)
Time Frame: From first dose of study drug up to 12 months
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Serious ADR is defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.
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From first dose of study drug up to 12 months
|
Number of Participants With Unexpected AEs
Time Frame: From first dose of study drug up to 12 months
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AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, etc., which do not necessarily have a causal relationship with the drug in question.
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From first dose of study drug up to 12 months
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Number of Participants With Unexpected ADRs
Time Frame: From first dose of study drug up to 12 months
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An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out.
AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
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From first dose of study drug up to 12 months
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Number of Participants With Known ADRs
Time Frame: From first dose of study drug up to 12 months
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An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out.
AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
|
From first dose of study drug up to 12 months
|
Number of Participants With Non-serious ADRs
Time Frame: From first dose of study drug up to 12 months
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An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out.
AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
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From first dose of study drug up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Overall Response
Time Frame: From first dose of study drug up to 12 months
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Overall response will include complete response (CR), and partial response (PR).
The confirmation of overall response will be based on investigator's judgement.
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From first dose of study drug up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2019
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
January 26, 2022
First Submitted That Met QC Criteria
January 26, 2022
First Posted (Actual)
February 4, 2022
Study Record Updates
Last Update Posted (Estimate)
January 9, 2023
Last Update Submitted That Met QC Criteria
January 6, 2023
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7080-M082-509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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