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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001397
Receipt No. R000001356
Scientific Title LONG- EFFECT OF BCAA ON CLINICAL FEATURES OF HCV-RELATED CHRONIC LIVER DISEASE TRIAL
Date of disclosure of the study information 2008/09/29
Last modified on 2012/03/27

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Basic information
Public title LONG- EFFECT OF BCAA ON CLINICAL FEATURES OF HCV-RELATED CHRONIC LIVER DISEASE TRIAL

Acronym LEEBOC TRIAL
Scientific Title LONG- EFFECT OF BCAA ON CLINICAL FEATURES OF HCV-RELATED CHRONIC LIVER DISEASE TRIAL

Scientific Title:Acronym LEEBOC TRIAL
Region
Japan

Condition
Condition HCV related chronic liver disease except for decompensated cirrhosis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of long-term oral supplementation with branched-chain amino acids (BCAA) on the inhibition of carcinogenesis in patients with HCV related chronic liver disease except for decompensated cirrhosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Development of hepatocellular carcinoma.
Key secondary outcomes 1) incidence of the ascites 2) incidence of the edema 3) incidence of the hepatic encephalopathy 4) incidence of jaundice 5) progress of the esophageal or gastric varices 6) transition of the glucose metabolic marker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 4 g BCAA preparation containing 952 mg l-isoleucine, 1904 mg l-leucine, and 1144 mg l-valine (LIVACT Granules®; Ajinomoto Co., Inc., Tokyo) administered orally three times daily after meals and dietary therapy for four years
Interventions/Control_2 dietary therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient who has HCV-RNA positive and diagnosed HCV related chronic liver disease.
2) Patient whose serum albumin level is less than 3.9g/dl.
3) Patient whose age is more than twenty.
4) Patient who gives written informed concent.
Key exclusion criteria 1) Patient whose serum total bilirubin level is more than 2.0 mg/dl.
2) Patient whose serum creatinine level is more than 2.1 mg/dl.
3) Patient who has hepatocellular carcinoma.
4) Patient who has ascites.
5) Patient who has edema.
6) Patient who has hepatic encephalopathy.
7) Patient who has esophageal varices requiring treatment or treatment history.
8) Patient who is heavy drinker
9) Patient who has diabetes requiring treatment
10) Patients who is in pregnancy

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetsugu Saito, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email hosenao@db3.so-net.ne.jp

Sponsor
Institute Keio University,Division of Gastroenterology,Department of Internal Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor KITASATO INSTITUTEHOSPITAL
SAISEIKAI CENTRAL HOSPITAL
NIHON KOKAN HOSPITAL
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
2008 Year 09 Month 29 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 No longer recruiting
Date of protocol fixation
2008 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2013 Year 10 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
2008 Year 09 Month 27 Day
Last modified on
2012 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001356

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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