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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016181
Receipt No. R000018783
Scientific Title Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Date of disclosure of the study information 2015/01/14
Last modified on 2016/08/31

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Basic information
Public title Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Acronym Efficacy of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Scientific Title Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Scientific Title:Acronym Efficacy of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Region
Japan

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

Objectives
Narrative objectives1 To assessment of efficacy and safety of daclatasvir and asunaprevir in chronic hepatits C patients with hemodialysis .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Sustained virologic response rate at 24 weeks post-treatment
Key secondary outcomes Safety
The factor associated with sustained virologic response
Emergence of drug-resistant virus
Cumulative incidence of hepatocellular carcinoma

Base
Study type

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Chronic hepatitis or cirrhosis patients with HCV genotype 1
(2) Patients with hemodialysis
(3) Patients with 20 years of age and older
Key exclusion criteria (1) Decompensated cirrhosis, Liver failure
(2)patients with hepatic cell carcinoma
(3) Co-infection with hepatitis B virus
Co-infection with anti- humanimmunodeficiency virus


Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name uojima haruki
Organization shonan kamakura general hospital
Division name department of gastroenterology
Zip code
Address 1370-1 okamoto,kamakura, kanagawa, japan
TEL 0467-46-1717
Email kiruha555@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name uojima haruki
Organization shonan kamakura general hospital
Division name department of gastroenterology
Zip code
Address 1370-1 o,kamakura, kanagawa, japan
TEL 0467-46-1717
Homepage URL
Email kiruha555@yahoo.co.jp

Sponsor
Institute shonan kamakura general 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 01 Month 14 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
2014 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 14 Day
Last follow-up date
2016 Year 08 Month 28 Day
Date of closure to data entry
2016 Year 08 Month 28 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information none

Management information
Registered date
2015 Year 01 Month 12 Day
Last modified on
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018783

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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