UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006978
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

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Basic information

Public 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

Acronym

BLOCK study

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

Scientific Title:Acronym

BLOCK study

Region

Japan


Condition

Condition

Hepatitis c virus related liver cirrhosis

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Time to hepatic carcinogenesis

Key secondary outcomes

Time to progression of liver cirrrhosis
The change in serum albumin level
The change in markers of glucose metabolism


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of BCAA(LIVACT granules 12g/day) with appropriate nutrition for liver cirrhosis

Interventions/Control_2

standard treatment with appropriate nutrition for liver cirrhosis

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) 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

Key exclusion criteria

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.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatoshi Kudo

Organization

Kinki University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuomi Ueshima

Organization

Kinki University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Homepage URL


Email

kaz-ues@med.kindai.ac.jp


Sponsor or person

Institute

Japan Liver Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Japan Liver Oncology Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

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)


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 01 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

2011 Year 04 Month 12 Day

Date of IRB

2011 Year 04 Month 12 Day

Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2016 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

2011 Year 12 Month 28 Day

Last modified on

2023 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/26 BLOCK:UMIN固定用データ.xlsx