UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized control study to investigate the effect of rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Title of the study (Brief title)	Randomized control study to investigate the effect of rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Region	Japan

Condition
Condition	Hepatocellular carcinoma (HCC) with chronic liver diseases by Hepatitis C virus (HCV) infection (after radical HCC treatment)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Rifampicin on prevention of recurrence in patients of HCV-related HCC after radical treatment of HCC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Disease-free survival
Key secondary outcomes	(1) Serum alanine aminotransferase, (2) Serum aspartate aminotransferase, (3) Serum lactate dehydrogenase, (4) Serum alpha-fetoprotein, (5) Serum lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), (6) Serum protein induced by vitamin K absence or antagonist-II (PIVKA-II), (7) Serum level of Vascular endothelial growth factor, (8) One-year recurrence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Oral administration of Rifampicin 300 mg/day everyday for 84 weeks
Interventions/Control_2	Best supprtive care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients aged >= 20 years to < 80 years at informed consent and notified disease (2) Outpatients (3) Patients at 30 to 60 days after radical HCC treatment (4) Patients who meet following criteria before radical HCC treatment a. Patients with no preceding treatment, and patients with single or double preceding HCC treatment b. Patients who have been diagnosed with HCC by histologically or typical diagnostic images (using dynamic CT and/or Gd-EOB-DTPA-enhanced MRI) c. Patients without preoperative evidence of macroscopic vascular invasion (Vp, Vv, B) (5) Patients with an ECOG performance status (PS) of 0 or 1 (6) Written Informed consent must be obtained
Key exclusion criteria	(1) Not consent to observe the regulation about concomitant drug and concomitant therapy (2) Patients with complications that influence on serum alanine aminotransferase or aspartate aminotransferase, including polymyositis, acute myocardial infarction, and gallstone. (3) Patients under dialysis therapy (4) Patients with liver diseases due to chronic viral hepatitis (except for Hepatitis C virus), liver failure, alcohol abuse, drug-induced liver damage, autoimuune hepatitis, and primary biliary cirrhosis. (5) Patients with obstruction of bile duct. Patients with severe liver diseases, who meet one of following criteria; # Child-Pugh grade C # Hepatic encephalopathy # Total bilirubin >= 3mg/dL # Decompensated liver cirrhosis # AST >= 500IU/L # ALT >= 500IU/L (6) Patient with any other cancer (7) Patients of porphyria (8) Past history of hypersensitivity for Rifampicin (9) Preceding administration of other investigational agent within 24 weeks before enrollment of this study (10) Patients with pregnancy, lactation or possibility of pregnancy. Not consent to use contraceptive method during the study treatment. (11) Patients with active infectious diseases due to methicillin-resistant Staphylococcus aureus, atypical Mycobacteria, and Mycobacterium tuberculosis (12) Patients under chemotherapy of anti-cancer drug (Local or Systemic) or radiotherapy (13) Preceding enrollment of this study, and preceding administration of Rifampicin in this study (14) Any patients judged by the investigators to be unfit to participate in the study
Target sample size	40

Research contact person
Name of lead principal investigator	Sei Kakinuma
Organization	University Hospital of Medicine, Tokyo Medical and Dental University
Division name	Department of Gastroenterology and Hepatology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-3813-6111
Email	skakinuma.gast@tmd.ac.jp

Public contact
Name of contact person	Sei Kakinuma
Organization	University Hospital of Medicine, Tokyo Medical and Dental University
Division name	Department of Gastroenterology and Hepatology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-3813-6111
Homepage URL
Email	dept.gast@tmd.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	GeneCare Research Institute Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Japan Agency for Medical Research and development (AMED)
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科歯科大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 30 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 05 Day
Last modified on	2017 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009000