UMIN-CTR Clinical Trial

Basic information
Public title	Effects of entecavir plus branched-chain amino acids versus entecavir alone in nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection : An open-label randomized controlled trial.
Acronym	Trial M
Scientific Title	Effects of entecavir plus branched-chain amino acids versus entecavir alone in nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection : An open-label randomized controlled trial.
Scientific Title:Acronym	Trial M
Region	Japan

Condition
Condition	Chronic hepatitis B
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy of entecavir plus branched-chain amino acids
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	the change from baseline in mean serum HBV-DNA level at week 12
Key secondary outcomes	the change from baseline in mean serum HBV-DNA level at week 4 and 8 the change from baseline in mean serum albumin level, ALT level, total bilirubin level and total cholesterol level at week 12 Safety (moniterd clinical and laboratory evaluation)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	entecavir plus branched-chain amino acids
Interventions/Control_2	entecavir alone2
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) nucleoside-na&#239;ve Japanese adult patients with chronic hepatitis B virus infection 2)albumin level 4.0 g/dl or less
Key exclusion criteria	1) a history of allergy induced by nucleoside analog or exposure to nucleoside analogs 2) had a history of oral BCAA supplementation for 6 months or longer 3) Pregnant or lactating women and women who may be pregnant 4) had major complication of liver cirrhosis, such as HCC, variceal bleeding, hepatic encephalopathy or ascites requiring diuretics, 5) had other nonhepatic major diseases 6) Patients with other liver disease (e.g., hepatitis C virus, alchol) 7) Judged by investigator not to be appropriate for inclusion in this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuaki Chayama
Organization	graduate school of biomedical science, Hiroshima university.
Division name	Department and medicine and molecular science
Zip code
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Email

Public contact
Name of contact person	1st name Middle name Last name Yoshiiku Kawakami
Organization	graduate school of biomedical science, Hiroshima university
Division name	Department and medicine and molecular science
Zip code
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Homepage URL
Email

Sponsor
Institute	Hiroshima liver study group
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	川上消化器内科クリニック、広島赤十字原爆病院、ＪＡ尾道総合病院、県立広島病院、呉医療センター、安佐市民病院、中国労災病院、広島鉄道病院、三次中央病院

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 16 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	Completed
Date of protocol fixation	2010 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2013 Year 03 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	2010 Year 06 Month 16 Day
Last modified on	2013 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004213

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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