UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036150 |
|---|---|
| Receipt number | R000040761 |
| Scientific Title | Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2024/11/04 19:46:36 |
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Basic information
Public title
Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Acronym
Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Scientific Title
Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Scientific Title:Acronym
Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Region
| Japan |
Condition
Condition
hepatitis C virus associated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the treatment effect of antiviral therapy and the effect of improvement of disease condition in hepatitis C virus associated liver cirrhotic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virologic response rate and factors associated with it
Key secondary outcomes
Cumulative HCC incidence rate and factors associated with it.
Changes in Child-pugh score, MELD score and MELD-Na score and factors associated with these.
Cumulative survival rate, all cause mortality, liver disease related mortality and decompensated cirrhotic events and factors associated with these.
safety
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HCV associated liver cirrhotic patients who were started DAA therapy between February 1 2019 and December 31 2021.
Key exclusion criteria
Patients who were judged inadequate to participate by researchers.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka university graduate school of medicine
Division name
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Hikita |
Organization
Osaka university graduate school of medicine
Division name
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
Homepage URL
hikita@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Univercity Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2019 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
478
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040761
