UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006888 |
|---|---|
| Receipt number | R000008138 |
| Scientific Title | Impact of genetic polymorphism on response to antiviral treatment in patients with hepatitis C |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2022/12/21 10:04:02 |
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Basic information
Public title
Impact of genetic polymorphism on response to antiviral treatment in patients with hepatitis C
Acronym
Impact of genetic polymorphism on response to antiviral treatment in patients with hepatitis C
Scientific Title
Impact of genetic polymorphism on response to antiviral treatment in patients with hepatitis C
Scientific Title:Acronym
Impact of genetic polymorphism on response to antiviral treatment in patients with hepatitis C
Region
| Japan |
Condition
Condition
hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
elucidate the relation between genetic polymorphism and effect of antiviral treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)elucidate the relation between ITPA polymorphism and effect of antiviral treatment
2)elucidate the relation between IL28B polymorphism and effect of antiviral treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with hepatitis C or cirrhotic patients with HCV antibody-positive or HCV-RNA-positive.
Key exclusion criteria
1) patients during pregnancy, during breast-feed, having a plan of pregnancy
2) patients with autoimmune disease
3) patients with malignant disease
4) patients with bleeding tendency (prothorombin time<50%, platelet count<30,000/mm3)
5) patients disqualified by principal investigator
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryotaro Sakamori |
Organization
Osaka University Graduate School of Medicine
Division name
The department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaooka Suita Osaka
TEL
0668793621
sakamori@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Tahata |
Organization
Osaka University Graduate School of Medicine
Division name
The department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaooka Suita Osaka
TEL
06-6879-3621
Homepage URL
yuki.tahata@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
The department of Gastroenterology and Hepatology
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The department of Gastroenterology and Hepatology
Osaka University Graduate School of Medicine
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
| 2011 | Year | 12 | Month | 28 | 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
| 2011 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
starting observation study about patients who provide consent
Management information
Registered date
| 2011 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008138
