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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012065
Receipt No. R000014075
Scientific Title Effect of angiotensin II receptor type 1 blocker and branched-chain amino acids on small intestinal pathological lesions in patients with liver cirrhosis
Date of disclosure of the study information 2013/10/21
Last modified on 2018/10/25

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Basic information
Public title Effect of angiotensin II receptor type 1 blocker and branched-chain amino acids on small intestinal pathological lesions in patients with liver cirrhosis
Acronym Effect of ARB and BCAA on small intestine of cirrhotic patients
Scientific Title Effect of angiotensin II receptor type 1 blocker and branched-chain amino acids on small intestinal pathological lesions in patients with liver cirrhosis
Scientific Title:Acronym Effect of ARB and BCAA on small intestine of cirrhotic patients
Region
Japan

Condition
Condition Liver cirrhosis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the features of small intestinal lesions of liver cirrhotic patients and to evaluate the effect of ARB and BCAA on them
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Periods between the date of primary resistration and the date of newly occurred varices recognition in digestive organs
Key secondary outcomes Periods between the date of primary resistration and the date of varices rupture (or very similar situation to rupture) in digestive organs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1) Angiotensin II receptor blocker
2) Branched-chain amino acids

Use normal dose
Interventions/Control_2 1) Angiotensin II receptor blocker

Use normal dose
Interventions/Control_3 1) Branched-chain amino acids

Use normal dose
Interventions/Control_4 No medication
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) Patients over 20 years old
2) Patients obtained written informed consent
3) Life expectancy of at least 12 weeks
4) Patients with an ECOG Performance Status (PS) score of 0 or 1
5) Patinets with Child-Pugh class A, B cirrhosis
6) Adequate organ function
a.Hb>= 8.0g/dL
b.Neutrophil>=1500 /mm3
c.PLT>= 50000 /mm3
d.T-Bil< 3.0 mg/dL
e.AST and ALT<= within 6 times of normal limit
f.Cre<= within 1.5 times of normal limit
Key exclusion criteria 1) Patients with malignant tumor
2) Patients with severe heart disease
3) Patients with severe and active infectious disease except viral hepatitis
4) Patients with HIV
5) Patients with severe renal dysfunction
6) Patienst with intracranial tumor
7) Patients with on going refractory hepatic coma
8) Patients with refractory ascites and pleural effusion
9) Patients with crutial digestive bleedings within 4 weeks
10) Ptients with intravascular thrombosis within 6 months except portal thrombosis
11) Patients with the following issues
a. Systemic chemotherapy against HCC
b. Partial hepatectomy or local treatment against HCC within 4 weeks
c. Being treated with anticoagulant drugs
d. Being treated with invasive surgical therapy within 4 weeks
e. Having been treated with organ transplantation
f. Being treated with bone marrow transplantation within 4 weeks
12) Patients with oral intake difficulty
13) Patients with severe digestive diseases
14) Patients taking a tablet which would affect this clinical study
15) Patients without normal absorbing function
16) Patients having been resistered in other clinical study within 4 weeks
17) Pregnant woman, lactating woman, or a woman suspected of pregnancy
18) Patients with severe allergic reaction
19) Patients with drug abuse or psycological disorders
20) Patients taking aliskiren hemifumarate
21) Patients concluded to be inappropriate to participate in this study by their physitians
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KEI MORIYA
Organization Nara Medical University
Division name The third department of Internal Medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara, JAPAN
TEL 0744-22-3051
Email moriyak@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KEI MORIYA
Organization Nara Medical University
Division name The third department of internal medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara, JAPAN
TEL 0744-22-3051
Homepage URL
Email moriyak@naramed-u.ac.jp

Sponsor
Institute The third department of internal medicine, Nara Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 奈良県立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 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
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 21 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014075

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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