UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039580 |
|---|---|
| Receipt number | R000044283 |
| Scientific Title | The efficacy of HCV eradication with direct-acting antivirals on patients with cirrhosis |
| Date of disclosure of the study information | 2020/02/24 |
| Last modified on | 2020/02/24 10:20:44 |
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Basic information
Public title
The efficacy of HCV eradication with direct-acting antivirals on patients with cirrhosis
Acronym
The efficacy of HCV clearance
Scientific Title
The efficacy of HCV eradication with direct-acting antivirals on patients with cirrhosis
Scientific Title:Acronym
The efficacy of HCV clearance
Region
| Japan |
Condition
Condition
HCV-related cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of HCV eradication with direct-acting antivirals on patients with cirrhosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Portal hemodynamic change
Key secondary outcomes
Change of liver function/ fibrosis/inflammation/protein expression/gut microbiome
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HCV realted cirrhosis
Key exclusion criteria
viable HCC
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Graduate School of Medicine
Division name
Deartment of Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
0432262083
takakon@chiba-u.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
0432262083
Homepage URL
takakon@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Chiba Univesity Graduate School of Medicine, IRB
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
Tel
0432227171
igaku-rinri@office.chiba-u.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
| 2020 | Year | 02 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 02 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044283
