UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002262 |
|---|---|
| Receipt number | R000002768 |
| Scientific Title | Comprehensive analyses of viral factors in hepatitis C patients receiving interferon-related therapy. |
| Date of disclosure of the study information | 2013/03/31 |
| Last modified on | 2019/02/04 15:14:41 |
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Basic information
Public title
Comprehensive analyses of viral factors in hepatitis C patients receiving interferon-related therapy.
Acronym
Comprehensive analyses of viral factors in hepatitis C patients
Scientific Title
Comprehensive analyses of viral factors in hepatitis C patients receiving interferon-related therapy.
Scientific Title:Acronym
Comprehensive analyses of viral factors in hepatitis C patients
Region
| Japan |
Condition
Condition
hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the viral factors that determine the efficacy of anti-viral therapy on patients with chronic hepatitis C
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the efficacy of the therapy and the mutations of hepatitis C viral sequences
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis caused by hepatitis C virus infeciton
Key exclusion criteria
Patients without the indication of anti-viral therapy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Marusawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Dep.Gastroenterology and Hepatology
Zip code
Address
Shogoin-Kawaracho 54, Sakyo-ku, Kyoto
TEL
075-751-4319
maru@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Marusawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Dep.Gastroenterology and Hepatology
Zip code
Address
Shogoin-Kawaracho 54, Sakyo-ku, Kyoto
TEL
075-751-4319
Homepage URL
maru@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 03 | Month | 31 | 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
| 2009 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine whether the certain viral mutations of hepatitis C genomes are associated with the efficacy of the anti-viral therapy in patients with chronic hepatitis C.
Management information
Registered date
| 2009 | Year | 07 | Month | 28 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002768
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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