UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003468 |
|---|---|
| Receipt number | R000004196 |
| Scientific Title | Additional effect of statin to PegIFN/Ribavirin treatment in chronic hepatitis C patients |
| Date of disclosure of the study information | 2010/04/09 |
| Last modified on | 2016/10/14 08:56:35 |
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Basic information
Public title
Additional effect of statin to PegIFN/Ribavirin treatment in chronic hepatitis C patients
Acronym
PEG-IFN alfa2b + Ribavirin combination therapy + statin
Scientific Title
Additional effect of statin to PegIFN/Ribavirin treatment in chronic hepatitis C patients
Scientific Title:Acronym
PEG-IFN alfa2b + Ribavirin combination therapy + statin
Region
| Japan |
Condition
Condition
Hepatitis C of genotype1 in high viral load(>=5logIU/mL Taqman) and Hypercholesteremia
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the triple treatment with statin, PegIFN and Ribavirin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SVR rate
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients receive PegIFN alfa2b and Ribavirin and statin . Any type of statins are available to be used and each drug is used according to the package insert.
The duration of treatment is basically 48weeks. However 72-week treatment is available if HCV-RNA negative by the 12-week is not accomplished.
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
1)Positive for antibody to HCV
2)HCV RNA of genotype is 1b
3)High HCV RNA levels (>=5.0 logIU/mL)
4)Without HCC
Key exclusion criteria
1) Used Ribavirin in previous treatments
2) Pregnant , possibly pregnant or lactating women
3) Patients with severe heart disease
4) Chronic kidney failure or creatinine clearance of <=50 mL/min
5) Current or history of severe psychiatric disorder
6) Autoimmune hepatitis
7) Intolerance to statin
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayoshi Ito |
Organization
Showa University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-5-8,Hatanodai,shinagawa-ku,Tokyo,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayoshi Ito |
Organization
Showa University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-5-8,Hatanodai,shinagawa-ku,Tokyo,Japan
TEL
03-3784-8535
Homepage URL
tito@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
PERFECT Study Group
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 | 04 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2010 | Year | 04 | Month | 09 | Day |
Last modified on
| 2016 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004196
| 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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| Registered date | File name |
