UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003363 |
|---|---|
| Receipt number | 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 10:29:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tsawada@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004088
