UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005815 |
|---|---|
| Receipt number | R000006875 |
| Scientific Title | Efficacy of selective estrogen receptor modulator in pegylated interferon alpha plus ribavirin treatment for menopausal women with chronic hepatitis C women |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2011/06/20 20:15:57 |
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Basic information
Public title
Efficacy of selective estrogen receptor modulator in pegylated interferon alpha plus ribavirin treatment for menopausal women with chronic hepatitis C women
Acronym
Selective estrogen receptor modulator in pegylated interferon alpha plus ribavirin treatment
Scientific Title
Efficacy of selective estrogen receptor modulator in pegylated interferon alpha plus ribavirin treatment for menopausal women with chronic hepatitis C women
Scientific Title:Acronym
Selective estrogen receptor modulator in pegylated interferon alpha plus ribavirin treatment
Region
| Japan |
Condition
Condition
Menopausal women with chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this study, we tested the hypothesis that selective estrogen receptor modulator (SERM), raloxifene, can give an impact of efficacy in pegylated interferon alpha plus ribavirin treatment as the current standard of care (SOC) for menopausal women with chronic hepatitis C women.
Basic objectives2
Others
Basic objectives -Others
Genotyping of the polymorphism in the interleukin-28B (IL28B) gene region (rs8099917) of chromosome 19 was performed on DNA collected from all patients.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Virological response was evaluated by Abbott RealTime PCR assay.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are randomly separated into two treatment groups: raloxifene plus pegylated interferon alpha plus ribavirin treatment as the current standard of care (SOC) and SOC only groups from 2010 to 2011.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
All patients are menopausal women with chronic hepatitis C and osteoporosis, and satisfy the following criteria: (1) positivity for hepatitis C virus (HCV) antibody and HCV RNA (2) a history of an increased alanine aminotransferase level for over six months.
Key exclusion criteria
Exclusion criteria for the study were: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation; (3) excessive active alcohol consumption (> 60 g/day converted into ethanol) or drug abuse; (4) suspected hepatocellular carcinoma at entry; or (5) treatment with antiviral or immunosuppressive agents prior to enrollment.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Hayashi |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5909
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5909
Homepage URL
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of General Internal Medicine, Kyushu University Hospital
Organization
Division
Category of Funding Organization
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 | 06 | Month | 20 | 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
| 2008 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2011 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006875
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
