Unique ID issued by UMIN | UMIN000006978 |
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Receipt number | R000008157 |
Scientific Title | BCAA Granule for patients with Hepatitis C virus-related Liver Cirrhosis and Insulin Resistance On the Effect of Reduction of Carcinogenic RisK in the Liver |
Date of disclosure of the study information | 2012/01/01 |
Last modified on | 2023/01/05 09:57:02 |
BCAA Granule for patients with Hepatitis C virus-related Liver Cirrhosis and Insulin Resistance On the Effect of Reduction
of Carcinogenic RisK in the Liver
BLOCK study
BCAA Granule for patients with Hepatitis C virus-related Liver Cirrhosis and Insulin Resistance On the Effect of Reduction
of Carcinogenic RisK in the Liver
BLOCK study
Japan |
Hepatitis c virus related liver cirrhosis
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
NO
The purpose of this study is to investigate whether BCAA granule reduces hepatic carcinogenic risk for patients with hepatitis C virus-related liver cirrhosis and insulin resistance
Safety,Efficacy
Confirmatory
Phase III
Time to hepatic carcinogenesis
Time to progression of liver cirrrhosis
The change in serum albumin level
The change in markers of glucose metabolism
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Oral administration of BCAA(LIVACT granules 12g/day) with appropriate nutrition for liver cirrhosis
standard treatment with appropriate nutrition for liver cirrhosis
20 | years-old | <= |
Not applicable |
Male and Female
1) 20 Years and older
2) Written infomed concent
3) Hepatitis C related compensative liver cirrhosis
4) Serum albumin level >= 3.6mg/dl
5) AST and ALT >= ULN
6) HOMA-R >=2.5
7) ECOG Performance status 0 or 1
1) Oral administration of BCAA or nutritional sulpplement including BCAA within 4 weeks prior to study entry
2) HBV infection
3) History of hepatic encephalopathy
4) Serum bilirubin levels >= 3.0mg/dl
5) Uncontrollable ascites or edema or pleural effusion
6) Cirrhotic status of Child-Pugh B or C
7) Alcohol abuse
8) High risk of rupture of esophageal varices
9) Renal failure
10) congenital disorders of aminoacid metabolism
11) Diabetes mellitus requiring medication
12) Interferon therapy
13) History of hepatocellular carcinoma
14) History of malignant tumors
15) Severe heart disease
16) Severe and active infection
17) Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
18) Embolization or infarction within 6 months prior to study entry.
19) Surgical procedure within 4 weeks prior to start of study drug
20) History of organ allograft
21) Bone marrow transplantation or peripheral blood stemcell transplantation within 4 weeks prior to study entry
22) Patients unable to swallow oral medications
23) Any gastrointestinal disease or disorder that may affect to the absorption of drug or pharmacokinetics
24) Medication that may affect to the absorption of drug or pharmacokinetics.
25) Any disease or disorder that may affect the evaluation of study drug.
26) Entry to the other clinical trial within 4 weeks prior to entry to this study.
27) Pregnant or breast-feeding patients
28) Known allergy to the investigational agent or any agent given in association with this trial
29) Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results.
30) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
150
1st name | |
Middle name | |
Last name | Masatoshi Kudo |
Kinki University Faculty of Medicine
Department of Gastroenterology and Hepatology
377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
072-366-0221
1st name | |
Middle name | |
Last name | Kazuomi Ueshima |
Kinki University Faculty of Medicine
Department of Gastroenterology and Hepatology
377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
072-366-0221
kaz-ues@med.kindai.ac.jp
Japan Liver Oncology Group
Japan Liver Oncology Group
Other
NO
近畿大学病院(大阪府)
大阪赤十字病院(大阪府)
市立池田病院(大阪府)
大阪医科大学病院(大阪府)
日赤和歌山医療センター(和歌山県)
神戸市立医療センター中央市民病院(兵庫県)
関西医科大学枚方病院(大阪府)
高槻赤十字病院(大阪府)
大阪府立成人病センター(大阪府)
姫路赤十字病院(兵庫県)
神鋼病院(兵庫県)
神戸朝日病院(兵庫県)
高松赤十字病院(香川県)
北野病院(大阪府)
近畿大学堺病院(大阪府)
関西電力病院(大阪府)
岸和田徳洲会病院(大阪府)
西神戸医療センター(兵庫県)
済生会和歌山病院(和歌山県)
市立堺病院(大阪府)
大阪厚生年金病院(大阪府)
加古川医療センター(兵庫県)
京都医療センター(京都府)
天理よろづ相談所病院(奈良県)
武蔵野赤十字病院(東京都)
大阪府立急性期総合医療センター(大阪府)
赤穂市民病院(兵庫県)
北里大学東病院(神奈川県)
奈良県立医科大学(奈良県)
2012 | Year | 01 | Month | 01 | Day |
Unpublished
Terminated
2011 | Year | 04 | Month | 12 | Day |
2011 | Year | 04 | Month | 12 | Day |
2012 | Year | 01 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 28 | Day |
2023 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008157
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2019/03/26 | BLOCK:UMIN固定用データ.xlsx |