UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001397
Receipt number 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 2022/04/08 09:43:46

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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 Hidetsugu
Middle name
Last name Saito

Organization

Keio University

Division name

Division of Gastroenterology,Department of Internal Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

0333531211

Email

nhosoe@keio.jp


Public contact

Name of contact person

1st name Naoki
Middle name
Last name Hosoe

Organization

Keio University

Division name

Division of Gastroenterology,Department of Internal Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

09064792029

Homepage URL


Email

nhosoe@keio.jp


Sponsor or person

Institute

Keio University,Division of Gastroenterology,Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio university

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

Keio university

Address

Shinjukuku, Shinanomachi35

Tel

0333231211

Email

nhosoe@keio.jp


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

Terminated

Date of protocol fixation

2008 Year 07 Month 01 Day

Date of IRB

2008 Year 08 Month 01 Day

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

2022 Year 04 Month 08 Day



Link to view the page

Value
https://center6.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