UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The beneficial effect of branched-chain amino acids with simeprevir with peginterferon alpha-2b plus ribavirin for chronic hepatitis C
Title of the study (Brief title)	The beneficial effect of branched-chain amino acids with simeprevir triple combination therapy for chronic hepatitis C
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 with simeprevir plus peginterferon plus ribavirin therapy for chronic hepatitis C patients by prospective randmized trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Sustained virological response
Key secondary outcomes	1) Negative conversion rate of HCV-RNA (at 4W, 12W, 24W of therapy) 2) Change in hemoglobin 3) Dose of drug (simeprevir, peginterferon, ribavirin) 4) Improvement of insulin resistance 5) Improvement of loss of zinc 6) Improvement of BTR 7) Occurrence of side effect

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Patients were treated by simeprevir plus peginterferon/ribavirin therapy with BCAA enriched supplement.
Interventions/Control_2	Patients were treated by simeprevir plus peginterferon/ribavirin therapy without BCAA enriched supplement.
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 who infected HCV-serotype1 2) age, over 20 years old and under 75 years old 3) male and female 4) patients who don't diagnosed cirrhosis by imaging or blood examination 5) patients who has no HCC by imaging examination
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	Isao Hidaka
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Minamikogushi, Uba, Yamaguchi
TEL	0836-22-2241
Email	isao-h@yamaguchi-u.ac.jp

Public contact
Name of contact person	Isao Hidaka
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Minamikogushi, Uba, Yamaguchi
TEL	0836-22-2241
Homepage URL
Email	isao-h@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Yamaguchi University 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)

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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 09 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 09 Day
Last modified on	2018 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019431