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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007667
Receipt No. R000008995
Scientific Title Open-label trial to investigate the effect of Rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Date of disclosure of the study information 2012/04/09
Last modified on 2017/04/19

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Basic information
Public title Open-label trial to investigate the effect of Rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Acronym Open-label trial to investigate the effect of Rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Scientific Title Open-label trial to investigate the effect of Rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Scientific Title:Acronym Open-label trial 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 Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Oral admistration 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
(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
1st name
Middle name
Last name Sei Kakinuma
Organization University Hospital of Medicine, Tokyo Medical and Dental University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-3813-6111
Email skakinuma.gast@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sei Kakinuma
Organization University Hospital of Medicine, Tokyo Medical and Dental University
Division name Department of Gastroenterology and Hepatology
Zip code
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 Tsuchiura Kyodo General Hospital
Name of secondary funder(s) Japan Agency for Medical Research and development (A-MED)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)
土浦協同病院(茨城県)

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 30 Day
Date of IRB
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
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
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/ctr_e/ctr_view.cgi?recptno=R000008995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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