UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003694 |
|---|---|
| Receipt number | R000004474 |
| Scientific Title | Effect of Vitamine D3 for the patients whith chronic hepatitis C who recieved PEG-interferon alpha plus ribavirin: possible applicaition for database establishment. |
| Date of disclosure of the study information | 2010/06/10 |
| Last modified on | 2021/03/12 14:22:17 |
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Basic information
Public title
Effect of Vitamine D3 for the patients whith chronic hepatitis C who recieved PEG-interferon alpha plus ribavirin: possible applicaition for database establishment.
Acronym
EVIDENCE study
Scientific Title
Effect of Vitamine D3 for the patients whith chronic hepatitis C who recieved PEG-interferon alpha plus ribavirin: possible applicaition for database establishment.
Scientific Title:Acronym
EVIDENCE study
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Effects of Vitamine D3 during PEG-interferon alpha plus ribavirin treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained viral response (SVR)
Key secondary outcomes
Base
Study type
Interventional
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
Vitamine D3, PEG-interferon alpha and ribavirin
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 chronic hepatits C complicating with osteoporosis.
Key exclusion criteria
Any contraindication for (PEG) interferon, ribavirin, and Vitamine D3 suppliments.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Yoshiyuki Ueno |
Organization
Tohoku Univerisity Graduate School of Medicine
Division name
Div. Gastroenterology
Zip code
9808574
Address
1-1 Seiryo, Aobaku, Sendai
TEL
0227177171
yueno@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ueno |
Organization
Tohoku Univerisity Graduate School of Medicine
Division name
Div. Gastroenterology
Zip code
9808574
Address
1-1 Seiryo, Aobaku, Sendai
TEL
022-717-7171
Homepage URL
yoshiyuueno-gi@umin.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku Univerisity Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Industry based non-specific funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Tohoku University Graduate School of Medicine
Address
2-1 Seiryo, Aobaku, Sendai
Tel
0227177171
hisyo3@med.tohoku.ac.jp
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 | 10 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/23717463
Publication of results
Unpublished
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23717463
Number of participants that the trial has enrolled
10
Results
1(OH) vitamin D3 could improve the sensitivity of Peg-IFN/RBV therapy on HCV-infected hepatocytes by reducing the IP-10 production from PBMCs and ISGs expression in the liver.
Results date posted
| 2021 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chronic Hepatitis C
Participant flow
10 Patients were enrolled.
Adverse events
none except for already reported.
Outcome measures
sustained virological response (SVR24)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004474
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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