A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants

Carcinoma, Hepatocellular Clinical Trial

Official title:

A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225207
• Other study ID #: E7080-M082-509
• Status: Completed
• Start date: May 28, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants over 18 years

2. Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea

3. Participants who have given their consent to study participation about the use of the personal data and medical data

Exclusion Criteria:

1. Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)

2. Participants who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Other:
• Non-interventional
No intervention will be administered.

Locations

Country	Name	City	State
Korea, Republic of	Site #35	Bucheon	Gyeonggi-do
Korea, Republic of	Site #38	Bucheon	Gyeonggi-do
Korea, Republic of	Site #31	Busan
Korea, Republic of	Site #39	Busan
Korea, Republic of	Site #40	Busan
Korea, Republic of	Site #37	Changwon	Gyeongsangnam-do
Korea, Republic of	Site #32	Cheonan	Chungcheongnam-do
Korea, Republic of	Site #17	Daegu
Korea, Republic of	Site #18	Daegu
Korea, Republic of	Site #26	Daegu
Korea, Republic of	Site #30	Daegu
Korea, Republic of	Site #41	Daegu
Korea, Republic of	Site #19	Daejeon
Korea, Republic of	Site #20	Daejeon
Korea, Republic of	Site #24	Daejeon
Korea, Republic of	Site #34	Daejeon
Korea, Republic of	Site #06	Goyang	Gyeonggi-do
Korea, Republic of	Site #21	Incheon
Korea, Republic of	Site #33	Incheon
Korea, Republic of	Site #36	Incheon
Korea, Republic of	Site #03	Seongnam	Gyeonggi-do
Korea, Republic of	Site #01	Seoul
Korea, Republic of	Site #02	Seoul
Korea, Republic of	Site #04	Seoul
Korea, Republic of	Site #07	Seoul
Korea, Republic of	Site #08	Seoul
Korea, Republic of	Site #09	Seoul
Korea, Republic of	Site #10	Seoul
Korea, Republic of	Site #12	Seoul
Korea, Republic of	Site #16	Seoul
Korea, Republic of	Site #22	Seoul
Korea, Republic of	Site #23	Seoul
Korea, Republic of	Site #25	Seoul
Korea, Republic of	Site #42	Seoul
Korea, Republic of	Site #43	Seoul
Korea, Republic of	Site #44	Seoul
Korea, Republic of	Site #13	Suwon	Gyeonggi-do
Korea, Republic of	Site #27	Suwon	Gyeonggi-do
Korea, Republic of	Site #15	Uijeongbu	Gyeonggi-do
Korea, Republic of	Site #11	Ulsan
Korea, Republic of	Site #28	Yangsan	Gyeongsangnam-do
Korea, Republic of	Site #29	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of Participants With Overall Response	Overall response will include complete response (CR), and partial response (PR). The confirmation of overall response will be based on investigator's judgement.	From first dose of study drug up to 12 months