UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005598 |
|---|---|
| Receipt number | R000004266 |
| Scientific Title | Trial of novel combined therapy between interferon and hyperlipidemia for chronic hepatitis C patients |
| Date of disclosure of the study information | 2011/05/13 |
| Last modified on | 2011/05/13 15:59:25 |
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Basic information
Public title
Trial of novel combined therapy between interferon and hyperlipidemia for chronic hepatitis C patients
Acronym
Novel combined therapy for chronic hepatitis C patients
Scientific Title
Trial of novel combined therapy between interferon and hyperlipidemia for chronic hepatitis C patients
Scientific Title:Acronym
Novel combined therapy for chronic hepatitis C patients
Region
| Japan |
Condition
Condition
chronic hepatitis type C
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We estimate safety as the effectiveness of the peginterferon alpha-2a (following PEG-IFN), Ribavirin (following RBV) and fluvastatin combination therapy for the chronic hepatitis C patient having the fatty liver.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
SVR rate(HCV RNA lasting negative)
Key secondary outcomes
SBR rate(ALT lasting normalization),the timing HCV RNA negative and adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A Fluvastatin(LOCHOL Tablets) 20~30mg/day is administered 12 weeks alone(The example of seriousness administers 60mg in the maximum).
Afterwards, administering of using together is done by the amount corresponding to weight it as for PEG-IFN (Pegasys)(once a week)and RBV(Copegas)(every day).
The HCV-RNA density in blood is measured once a month. Administering is extended until 72 weeks if it will not make gloomily by 12 weeks, and it will make it gloomily by 36 weeks.
Afterwards, it takes withdraw for 24 weeks, and the effect is judged.
Interventions/Control_2
Group B Administering of using together is done by the amount corresponding to weight it as for PEG-IFN (Pegasys)(once a week)and RBV(Copegas)(every day).
The HCV-RNA density in blood is measured once a month. Administering is extended until 72 weeks if it will not make gloomily by 12 weeks, and it will make it gloomily by 36 weeks.
Afterwards, it takes withdraw for 24 weeks, and the effect is judged.
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
Patient who applies to eligibility criteria for* by chronic hepatitis C (
Serogroup1(genotype1b)and the viral load in blood is HCV-RNA 5.0LogIU/ml or more).
*Patient with chronicity C type chronic hepatitis to which treatment resistance is expected by disorder of lipid metabolism(Patient who meets requirement more than one item either the following)
1.Triglyceride value 150mg/dL or more
2.Less than HDL cholesterol value 40mg/dL
3.Area 100cm3 or more of visceral fat
4.The female 25%or more by the body fat percentage man 22% or more.
Key exclusion criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yoshiki murakami |
Organization
Kyoto University Graduate School of Medicine
Division name
Center for Genomic Medicine
Zip code
Address
kyotoshi sakyouku shougoin kawaharatyou53
TEL
075-751-4192
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yoshiki murakami |
Organization
Kyoto University Graduate School of Medicine
Division name
Center for Genomic Medicine
Zip code
Address
kyotoshi sakyouku shougoin kawaharatyou53
TEL
075-751-4192
Homepage URL
ymurakami@genome.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Center for Genomic Medicine
Institute
Department
Personal name
Funding Source
Organization
kagakukenkyuuhi
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 05 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 13 | Day |
Last modified on
| 2011 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004266
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