♦Basic information
JapicCTI-No. JapicCTI-142495
♦Title of the study
Title of the study A phase 3, placebo-controlled, multi-center, randomized, double-blind trial to evaluate the efficacy and safety of K-333 (peretinoin) in patients with complete cure of hepatocellular carcinoma in Asia
Public title of the study A phase 3, placebo-controlled, multi-center, randomized, double-blind trial to evaluate the efficacy and safety of K-333 (peretinoin) in patients with complete cure of hepatocellular carcinoma in Asia
Primary sponsor Kowa Co., Ltd.
Secondary sponsor  
Study Type interventional (drug)
Summary The purpose of this study is to verify the superiority of K-333 600mg daily to placebo in terms of the recurrence-inhibiting effect in patients confirmed of showing a complete cure of hepatocellular carcinoma (HCC), with the recurrence-free survival as the primary endpoint in placebo-controlled, multi-center, randomized, double-blind trial
♦Details of the study
Disease or condition Prevention of the recurrence of HCC in patients with complete cure of HBV or HCV-positive HCC
Intervention
Intervention name K-333
Classification name(code) of the intervention 429 (other antitumor agents)
Dosage And administration of the intervention Oral, 600mg daily
Control intervention name(code)/td> Placebo
Classification name(code) of the control intervention --- (other)
Dosage And administration of the control intervention Oral
Objectives of the study Prevention
Study phase Phase 3
Study design Placebo-controlled, multi-center, randomized, double-blind, parallel-group comparison study
Target sample size 600
Inclusion Criteria (1)Patients with the primary occurrence or the first recurrence of HBV- or HCV-related HCC
(2)Patients showing that a complete cure was confirmed by either local ablation or surgical resection
(3)Patients of the age of 20 years or older at the time of informed consent
etc.


AgeF     20years old or more
SexF     Both
Exclusion Criteria Patients with the HCC related to hepatitis virus other than HBV and HCV
etc.

Outcome
Primary Outcome Recurrence-free survival
Timepoints Time to recurrence of HCC or death, regardless of cause
Secondary Outcome (1)Disease-free survival
(2)Time to recurrence
Timepoints (1)Time to recurrence of HCC, death, regardless of cause, or occurrence of secondary cancer
(2)Time to recurrence of HCC
Institutions
Duration of the study 2014-3-1  `  2018-3-30
Study status
recruitment status Recruiting closed - ongoing study
Region Korea, Taiwan and Singapore
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Kowa Company, Ltd.
Division Pharmaceutical Division, Clinical Administration Dept.
Contact person or e-mail address etc. ctrdinfo@kowa.co.jp
Organization@(Scientific) Kowa Company, Ltd.
Division@(Scientific) Pharmaceutical Division, Clinical Administration Dept.
Contact person or e-mail address etc.@(Scientific) ctrdinfo@kowa.co.jp
♦Other
Source funded
Name of research funds
Other
♦History
History
2017/1/31   revised
2014/5/27   revised
2014/3/31   application date