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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017023
Receipt No. R000019741
Scientific Title Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.
Date of disclosure of the study information 2015/04/15
Last modified on 2017/07/13

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Basic information
Public title Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.
Acronym Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.
Scientific Title Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.
Scientific Title:Acronym Antiviral therapy for HCV using direct acting antiviral drugs in patients with chronic hepatitis C undergoing hemodialysis.
Region
Japan

Condition
Condition Patients with HCV genotype 1B infection who are undergoing maintenance hemodialysis.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the safety and efficacy of oral antiviral therapy for HCV using asunaprevir and daclatasvir in patients with chronic HCV infection undergoing hemodialysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Antiviral efficacy to eradicate HCV in patients with chronic HCV infection undergoing hemodialysis.
Key secondary outcomes Safety of oral antiviral therapy in patients with chronic HCV infection undergoing hemodialysis.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 asunaprevir 200mg twice daily and
daclatasvir 60mg once daily for 24 weeks.
Interventions/Control_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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with HCV genotype 1B infection who are undergoing maintenance hemodialysis.
Key exclusion criteria Patients infected with HCV other than HCV genotype 1B.
Patients with Child-Pugh class B or C cirrhosis.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Toyoda
Organization Ogaki Municipal Hospital
Division name Gastroenterology
Zip code
Address 4-86, Minaminokawa, Ogaki, Gifu
TEL 0584-81-3341(1561)
Email tkumada@he.mirai.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Toyoda
Organization Ogaki Municipal Hospital
Division name Gastroenterology
Zip code
Address 4-86, Minaminokawa, Ogaki, Gifu
TEL 0584-81-3341(1561)
Homepage URL
Email tkumada@he.mirai.ne.jp

Sponsor
Institute Ogaki Municipal Hospital
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 15 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
2014 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2014 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
2015 Year 04 Month 02 Day
Last modified on
2017 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019741

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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