UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of angiotensin II receptor type 1 blocker and branched-chain amino acids on small intestinal pathological lesions in patients with liver cirrhosis
Title of the study (Brief title)	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	KEI MORIYA
Organization	Nara Medical University
Division name	The third department of Internal Medicine
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Email	moriyak@naramed-u.ac.jp

Public contact
Name of contact person	KEI MORIYA
Organization	Nara Medical University
Division name	The third department of internal medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014075