A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants
A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
1 other identifier
observational
658
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2019
CompletedFirst Submitted
Initial submission to the registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedJanuary 9, 2023
January 1, 2022
2.7 years
January 26, 2022
January 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants With Serious Adverse Events (SAEs)
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.
From first dose of study drug up to 12 months
Number of Participants With Serious Adverse Drug Reactions (ADRs)
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.
From first dose of study drug up to 12 months
Number of Participants With Unexpected AEs
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.
From first dose of study drug up to 12 months
Number of Participants With Unexpected ADRs
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 Known ADRs
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
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
Secondary Outcomes (1)
Percentage of Participants With Overall Response
From first dose of study drug up to 12 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Participants with uHHC administered with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator.
You may qualify if:
- 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
You may not qualify if:
- Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
- Participants who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (42)
Site #32
Cheonan, Chungcheongnam-do, South Korea
Site #35
Bucheon-si, Gyeonggi-do, South Korea
Site #38
Bucheon-si, Gyeonggi-do, South Korea
Site #06
Goyang-si, Gyeonggi-do, South Korea
Site #03
Seongnam-si, Gyeonggi-do, South Korea
Site #13
Suwon, Gyeonggi-do, South Korea
Site #27
Suwon, Gyeonggi-do, South Korea
Site #15
Uijeongbu-si, Gyeonggi-do, South Korea
Site #37
Changwon, Gyeongsangnam-do, South Korea
Site #28
Yangsan, Gyeongsangnam-do, South Korea
Site #29
Yangsan, Gyeongsangnam-do, South Korea
Site #31
Busan, South Korea
Site #39
Busan, South Korea
Site #40
Busan, South Korea
Site #17
Daegu, South Korea
Site #18
Daegu, South Korea
Site #26
Daegu, South Korea
Site #30
Daegu, South Korea
Site #41
Daegu, South Korea
Site #19
Daejeon, South Korea
Site #20
Daejeon, South Korea
Site #24
Daejeon, South Korea
Site #34
Daejeon, South Korea
Site #21
Incheon, South Korea
Site #33
Incheon, South Korea
Site #36
Incheon, South Korea
Site #01
Seoul, South Korea
Site #02
Seoul, South Korea
Site #04
Seoul, South Korea
Site #07
Seoul, South Korea
Site #08
Seoul, South Korea
Site #09
Seoul, South Korea
Site #10
Seoul, South Korea
Site #12
Seoul, South Korea
Site #16
Seoul, South Korea
Site #22
Seoul, South Korea
Site #23
Seoul, South Korea
Site #25
Seoul, South Korea
Site #42
Seoul, South Korea
Site #43
Seoul, South Korea
Site #44
Seoul, South Korea
Site #11
Ulsan, South Korea
Related Publications (1)
Kang W, Kim YJ, Kim SU, Seo YS, Kim JW, Kim JH, Park SY, Baek YH, Kim KM, Lee HL, Yoon KT, Kim H, Cheong JY, Hwang JS, Kim JH, Kim KM, Sung PS, Kim J, Kim DY. Real-world safety and effectiveness of lenvatinib in unresectable hepatocellular carcinoma in Korea: post-marketing study. Future Oncol. 2024;20(37):2949-2959. doi: 10.1080/14796694.2024.2397328. Epub 2024 Sep 25.
PMID: 39320906DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2022
First Posted
February 4, 2022
Study Start
May 28, 2019
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
January 9, 2023
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.