UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Acronym	Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Scientific Title	Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Scientific Title:Acronym	Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Region	Japan

Condition
Condition	genotype 1 HCV patients receiving hemodialysis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we aim at examining the effect on iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare erythropoietic resistance index change between pre and post of treatment in the early intervention group and waiting intervention group
Key secondary outcomes	To assess Iron metabolism kinetics To assess mineral-bone metabolism kinetics To assess antiviral activity, the proportion of subjects who achieve undetectable HCV RNA at post treatment week 12 To assess safety To assess CLDQ-HCV, KDQOL-SF

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The subjects will be randomly assigned to the early intervention group and waiting intervention group. After entry in the study, the early intervention group will orally receive ASV 100 mg per dose twice daily and DCV 60 mg once daily for 24 weeks. After this treatment, the subjects will be observed for a further 24 week period.
Interventions/Control_2	The waiting intervention group will wait for the first 24 weeks and then receive the ASV/DCV combination therapy.
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)20 years old or older 2)Genotype 1 HCV -infected patients receiving hemodialysis 3)Patients who were provided with sufficient explanation before participating in this study and who provided written consent to participate in this study on their own free will.
Key exclusion criteria	1)Patients with decompensated cirrhosis 2)Patients complicated with hepatic cancer 3)Other patients whom the chief investigator or a sub-investigators considers inappropriate
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshitaka Arase
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	shimokasuya 143, Isehara, Kanagawa, Japan
TEL	0463-93-1121
Email	arase@tokai-u.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshitaka Arase
Organization	Tokai University Oiso Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan
TEL	0463-72-3211
Homepage URL
Email	arase@tokai-u.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb
Organization
Division
Category of Funding Organization	Profit organization
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	東海大学医学部付属病院 東海大学医学部付属大磯病院 東海大学医学部付属八王子病院 東海大学医学部付属東京病院 帝京大学医学部付属病院 順天堂大学医学部付属順天堂医院　 順天堂大学医学部付属練馬病院 医療法人社団　松和会　池上総合病院

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 03 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	2016 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 03 Day
Last modified on	2018 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027843

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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