UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037194 |
|---|---|
| Receipt number | R000042401 |
| Scientific Title | The analysis of pathological change in liver after eradication of Hepatitis C virus. |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2019/06/27 13:08:04 |
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Basic information
Public title
The analysis of pathological change in liver after eradication of Hepatitis C virus.
Acronym
The analysis of pathological change in liver after eradication of Hepatitis C virus.
Scientific Title
The analysis of pathological change in liver after eradication of Hepatitis C virus.
Scientific Title:Acronym
The analysis of pathological change in liver after eradication of Hepatitis C virus.
Region
| Japan |
Condition
Condition
liver cirrosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of this study is to clarify the pathological change in liver after eradication of HCV.
Basic objectives2
Others
Basic objectives -Others
the overall survival rate after SVR
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the liver function and pathological status after eradication of HCV.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who obtained SVR by DAA therapy.
the patients who under who underwent CT imaging at pretreatment, SVR, and 48 weeks after SVR.
Key exclusion criteria
the patients with any other liver diseases, including autoimmune hepatitis, drug-induced liver disease, and primary biliary cholangitis. Patients with Child-Pugh class B and C cirrhosis or who developed hepatocellular carcinoma during this study period were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | seko |
| Middle name | |
| Last name | yuya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
6028566
Address
465 kajiityou, kamigyo-ku, kyoto
TEL
0752515519
yuyaseko@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | seko |
| Middle name | |
| Last name | yuya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
6028566
Address
465 kajiityou, kamigyo-ku, kyoto
TEL
0752515519
Homepage URL
yuyaseko@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
465 kajiityou, kamigyo-ku, kyoto
Tel
0752515519
yuyaseko@koto.kpu-m.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 | 06 | Month | 27 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we investigated the relationship between liver volume and the changes in platelet counts of Japanese patients with HCV infection treated with DAAs who obtained SVR.
Management information
Registered date
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042401
