UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003685 |
|---|---|
| Receipt number | R000004464 |
| Scientific Title | Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C. |
| Date of disclosure of the study information | 2010/06/02 |
| Last modified on | 2018/12/07 23:01:50 |
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Basic information
Public title
Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Acronym
Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Scientific Title
Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Scientific Title:Acronym
Association between serum vitamin D level and response to antiviral therapy with peginterferon and ribavirin in patients with chronic hepatitis C.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the clinical significance of serum vitamin D level in the antiviral therapy of patients with chronic hepatitis C with peginterferon and ribavirin.
Basic objectives2
Others
Basic objectives -Others
Measurement of pretreatment serum vitamin D level in patients who underwent antiviral therapy with peginterferon and ribavirin. Comparison between pretreatment serum vitamin D level and treatment outcome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison between pretreatment serum vitamin D level and treatment outcome.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis C who underwent antiviral therapy with peginterferon and ribavirin and individuals for whom the clinical backgrounds were matched with patients with chronic hepatitis C (as controls).
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Kozawa |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
Address
Yanagito 1-1, Gifu, Gifu, Japan 501-1194
TEL
058-230-6214
okozawa@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Nishiwaki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
Address
Yanagito 1-1, Gifu, Gifu, Japan 501-1194
TEL
058-230-6217
Homepage URL
riemn@gifu-u.ac.jp
Sponsor or person
Institute
Department of Pharmacology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Terminated
Date of protocol fixation
| 2010 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2010 | Year | 05 | Month | 31 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004464
