UMIN-CTR Clinical Trial

Basic information
Public title	The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
Acronym	The beneficial effect of branched-chain amino acids with combined peginterferon plus ribavirin for chronic hepatitis C patients
Scientific Title	The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
Scientific Title:Acronym	The beneficial effect of branched-chain amino acids with combined peginterferon plus ribavirin for chronic hepatitis C patients
Region	Japan

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

Objectives
Narrative objectives1	We investigate the efficancy of branched-chain amino acid (BCAA) with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients by prospective randomized trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of nagative HCV RNA at 24 weeks after the initiation of treatment (The SVR rate)
Key secondary outcomes	1) Rate of negative HCV RNA (at 4 weeks, 12 weeks of combination therapy and end of the initiation therapy) 2) Change in hemoglobin 3) Dose of drug (peginterferon dose, ribavirin dose) 4) Change in insulin resistance 5) Occurrence of side effect

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Patients were treated by combination therapy of peg-interferon alpha 2b and ribavirin with or without BCAA. [group 1]therapy with 2 pack of the BCAA enriched supplement (aminofeel, TERUMO) [group 2]therapy without BCAA enriched supplement
Interventions/Control_2	Patients were treated by combination therapy of peg-interferon alpha 2b and ribavirin for 48-72 week in HCV-serotype 1, serum HCV RNA level of over 5.0 log IU/ml, for 24 week in HCV-serotype 1, serum HCV RNA level of under 5.0 log IU/ml and serotype 2.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients whose HCV-serotype 1 or 2 2) age, over 20 years old and under 75 years old 3) male and female 4) Patients who don't diagnosed cirrhosis by imaging findings or blood exsamination. 5) Patients who has no HCC by imaging findings.
Key exclusion criteria	1) Patient whose serum HCV RNA level under 5.0 log IU/ml and who taken initial therapy. 2) Patients with sensitivities for peg-interferon alpha 2b or other interferons. 3) Patients with sensitivities for vaccine. 4) Patients with sensitivities for ribavirin or other nucleic acid analogs. 5) a pregnant woman, or woman who may pregnant and who are nursing. 6) PAtients who had bad controled heart disease. 7) Patients who had hemoglobinemia. 8) Patients who had Chronic renal failure or whose creatinine clearance under 50ml/min. 9) Patients who had depression. 10) Patients who had severe liver disfunction or bile duct obstruction. 11) Patients who had cerebral hemorrhage or cerebral infarction. 12) PAtients who medicated by shousaikoto. 13) Patients who had autoimmune hepatitis. 14) Patients who had chronic hepatitis type B, alcoholic liver injury. 15) Patients who were disqualified by doctor in attendance.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Isao Hidaka
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Isao Hidaka
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterology, Yamaguchi Univercity Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Yamaguchi Univercity Graduate School of Medicine
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	山口大学医学部附属病院（山口県）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 24 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	Open public recruiting
Date of protocol fixation	2010 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 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 09 Month 22 Day
Last modified on	2012 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005026

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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