Clinical Trials Logo
  1. Home
  2. Carcinoma, Hepatocellular
  3. NCT03663114
  4. Details
NCT03663114 Clinical Trial

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

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03663114
Other study ID # LEN02T
Secondary ID E7080-M081-504
Status Completed
Phase
First received
Last updated
Start date July 2, 2018
Est. completion date February 20, 2020

Study information
Verified date January 2020
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 713
Est. completion date February 20, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

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 Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Hepatic Encephalopathy Risk Factors Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed. Baseline up to 1 year
Secondary Number of Participants with Hepatic Encephalopathy Baseline up to 1 year
See also
  Status Clinical Trial Phase
Completed NCT03289533 - A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100) Phase 1
Terminated NCT01141478 - Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria N/A
Recruiting NCT05580835 - PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma N/A
Active, not recruiting NCT05389527 - Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma Phase 2
Not yet recruiting NCT04560751 - TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)
Withdrawn NCT02939807 - A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma Phase 2
Completed NCT01915602 - Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC) Phase 2
Completed NCT04970212 - Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Recruiting NCT02403544 - Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma Phase 1
Completed NCT01897038 - A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma Phase 1
Terminated NCT01337492 - Pilot Study Sorafenib as Bridge to Orthotopic Liver Transplantation (OLT) Phase 0
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Completed NCT01003015 - Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma Phase 2
Terminated NCT01020812 - Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma Phase 1/Phase 2
Completed NCT00559455 - Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma Phase 2
Recruiting NCT00384800 - A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC) Phase 2
Terminated NCT00582400 - A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver Phase 2
Completed NCT00056992 - Testing of ADI-PEG in Hepatocellular Carcinoma Phase 2
Completed NCT02859324 - A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC) Phase 1/Phase 2
Terminated NCT02439008 - Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response N/A