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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003363
Receipt No. R000004088
Scientific Title Preventive effect on recurrence of hepatocellular carcinoma by branched chain amino acids after curative hepatectomy
Date of disclosure of the study information 2010/03/25
Last modified on 2012/05/02

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Basic information
Public title Preventive effect on recurrence of hepatocellular carcinoma by branched chain amino acids after curative hepatectomy
Acronym Prevention of HCC-recurrence by branched chain amino acids after hepatectomy
Scientific Title Preventive effect on recurrence of hepatocellular carcinoma by branched chain amino acids after curative hepatectomy
Scientific Title:Acronym Prevention of HCC-recurrence by branched chain amino acids after hepatectomy
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether branched chain amino acids prevent recurrence of hepatocellular carcinoma after curative surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes disease-free suravival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Intervention:term 4 years
dose Reevact 4g/time
frequency 3 times/day
Interventions/Control_2 Control 1:term 4 years
no drug
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with hepatocellular carcinoma who undergo curative hepatectomy at second Department of Surgery, Dokkyo Medical University
Key exclusion criteria 1)recurrence of hepatocellular carcinoma
2)Stage IV
3)Patients who were given branched chain amino acid within 4 weeks of regisration
4)hepatic coma>III
5)serum bilirubin level more than 3.0 mg/dL
6)Congenital abnormality of branched chain amino acids- metabolism
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Kubota
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address Kitakobayashi 880, Mibu, Shimotsuga, Tochigi
TEL 0282-86-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tokihiko Sawada
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address Kitakobayashi 880, Mibu, Shimotsuga, Tochigi
TEL 0282-86-1111
Homepage URL
Email tsawada@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 25 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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 23 Day
Last modified on
2012 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004088

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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