Unique ID issued by UMIN | UMIN000001397 |
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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 |
LONG- EFFECT OF BCAA ON CLINICAL FEATURES OF HCV-RELATED CHRONIC LIVER DISEASE TRIAL
LEEBOC TRIAL
LONG- EFFECT OF BCAA ON CLINICAL FEATURES OF HCV-RELATED CHRONIC LIVER DISEASE TRIAL
LEEBOC TRIAL
Japan |
HCV related chronic liver disease except for decompensated cirrhosis
Gastroenterology | Hepato-biliary-pancreatic medicine |
Others
NO
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.
Efficacy
Exploratory
Not applicable
Development of hepatocellular carcinoma.
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
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
dietary therapy
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
100
1st name | Hidetsugu |
Middle name | |
Last name | Saito |
Keio University
Division of Gastroenterology,Department of Internal Medicine
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
0333531211
nhosoe@keio.jp
1st name | Naoki |
Middle name | |
Last name | Hosoe |
Keio University
Division of Gastroenterology,Department of Internal Medicine
1608582
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
09064792029
nhosoe@keio.jp
Keio University,Division of Gastroenterology,Department of Internal Medicine
Keio university
Self funding
KITASATO INSTITUTEHOSPITAL
SAISEIKAI CENTRAL HOSPITAL
NIHON KOKAN HOSPITAL
Keio university
Shinjukuku, Shinanomachi35
0333231211
nhosoe@keio.jp
NO
2008 | Year | 09 | Month | 29 | Day |
Unpublished
Terminated
2008 | Year | 07 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2008 | Year | 09 | Month | 27 | Day |
2022 | Year | 04 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001356
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