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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016742
Receipt No. R000019431
Scientific Title The beneficial effect of branched-chain amino acids with simeprevir with peginterferon alpha-2b plus ribavirin for chronic hepatitis C
Date of disclosure of the study information 2015/03/09
Last modified on 2018/03/20

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Basic information
Public title The beneficial effect of branched-chain amino acids with simeprevir with peginterferon alpha-2b plus ribavirin for chronic hepatitis C
Acronym The beneficial effect of branched-chain amino acids with simeprevir triple combination therapy for chronic hepatitis C
Scientific Title The beneficial effect of branched-chain amino acids with simeprevir with peginterferon alpha-2b plus ribavirin for chronic hepatitis C
Scientific Title:Acronym 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
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, Uba, Yamaguchi
TEL 0836-22-2241
Email isao-h@yamaguchi-u.ac.jp

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, 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)

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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 09 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
2013 Year 12 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019431

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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