UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012065 |
|---|---|
| Receipt number | 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 09:54:25 |
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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
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
moriyak@naramed-u.ac.jp
Sponsor or person
Institute
The third department of internal medicine, Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014075
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