UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011331 |
|---|---|
| Receipt number | R000013227 |
| Scientific Title | Study of the effectiveness of IFN-beta monotherapy for hemodialysis patients with chronic hepatitis C |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2021/08/06 15:41:54 |
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Basic information
Public title
Study of the effectiveness of IFN-beta monotherapy for hemodialysis patients with chronic hepatitis C
Acronym
Study of the effectiveness of IFN-beta monotherapy for hemodialysis patients with chronic hepatitis C
Scientific Title
Study of the effectiveness of IFN-beta monotherapy for hemodialysis patients with chronic hepatitis C
Scientific Title:Acronym
Study of the effectiveness of IFN-beta monotherapy for hemodialysis 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
I consider the efficacy and safety of IFN-beta monotherapy for chronic hepatitis C patients during hemodialysis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HCV-RNA negative rate of 24 weeks after the end of treatment (SVR)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 20 years of age or older
Patients with HCV-RNA-positive that underwent hemodialysis
And with or without liver biopsy
Patients who consented to participate in the study
Key exclusion criteria
Patients with a history of hypersensitivity to against bovine-derived material and IFN preparation
Patients with chronic liver disease other autoimmune hepatitis, and alcoholic liver injury
Patients with liver failure and cirrhosis
Patients with abnormal thyroid function
Patients receiving in the Sho-saiko
Patient patient that may be pregnant or are pregnant, breast-feeding
Patients with severe depression
Patients with a history of hypersensitivity to any vaccine, such as biological products
Other patients who tested physician has determined is inappropriate participate in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sawako Uchida |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3905
sawako@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sawako Uchida |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3905
Homepage URL
sawako@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City 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
| 2013 | Year | 07 | Month | 31 | 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
| 2012 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013227
