UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007668 |
|---|---|
| Receipt number | R000009000 |
| Scientific Title | Randomized control study 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 11:01:03 |
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Basic information
Public title
Randomized control study to investigate the effect of rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Acronym
Randomized control study to investigate the effect of rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Scientific Title
Randomized control study to investigate the effect of rifampicin on prevention of recurrence in patients after radical treatment of primary hepatocellular carcinoma
Scientific Title:Acronym
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
| 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
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
dept.gast@tmd.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 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 |
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009000
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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