UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019452 |
|---|---|
| Receipt number | R000022485 |
| Scientific Title | The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2017/08/30 14:35:54 |
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Basic information
Public title
The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Acronym
The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Scientific Title
The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Scientific Title:Acronym
The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Region
| Japan |
Condition
Condition
Hepatitis C virus infection
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical significance of sustained virological response for hepatitis C virus-infected patients on hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extrahepatic manifestations of hepatitis c.
Key secondary outcomes
Vascular access patency rate, Death, Cardiovascular event.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Hepatitis C virus infected patients on hemodialysis.
Key exclusion criteria
Patients who do not agree with this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinobu Sato |
Organization
Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name
Department of nephrology
Zip code
Address
3-16-1 Tsutsumimachi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL
022-275-3111
sato-toshinobu@sendai.jcho.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Miyasaka |
Organization
Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name
Department of nephrology
Zip code
Address
3-16-1 Tsutsumimachi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL
022-275-3111
Homepage URL
miyasaka.yasunori@gmail.com
Sponsor or person
Institute
Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Institute
Department
Personal name
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
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 | 11 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2017 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022485
