UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031091 |
|---|---|
| Receipt number | R000035510 |
| Scientific Title | The effect of DAAs therapy for patients with HCV infection on prognosis and incidence of HCC |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/01/31 22:11:37 |
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Basic information
Public title
The effect of
DAAs therapy for patients
with HCV infection on prognosis and
incidence of HCC
Acronym
Effect of DAAs on incidence of HCC and prognosis
Scientific Title
The effect of
DAAs therapy for patients
with HCV infection on prognosis and
incidence of HCC
Scientific Title:Acronym
Effect of DAAs on incidence of HCC and prognosis
Region
| Japan |
Condition
Condition
Patients with HCV infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze the effect of
DAAs therapy for HCV infected patients on
HCC incidence,risk maker of incidence of
HCC and prognosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate incidence of HCC and
prognosis after HCV eradication.
To analyze risk factor of those
Key secondary outcomes
1 HCC incidence and prognosis in HD patients with HCV infection.
To compare HCC incidence and prognosis between patient with or without IFN-therapy
2 To investigate change in ALT and AFP
3 To investigate the change in liver fibrosis and steatosis after SVR
4 To investigate the change in lipid/glucose/Fe metabolismafter SVR
5 To investigate the rate of Hospitalization due to liver disease
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
HCV infected patients who were treated and achieved SVR between 2011 and 2026
Key exclusion criteria
1) Patients with difficult-to-control heart disease
2) Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine,
Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Hokkaido University
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) patients background
2) blood count
3) biochemical examination
4) tumor maker
5) HCV RNA, RAV
6) glucose, lipid metabolism
7) fibrosis maker
8) radiological exmamination
9) concomitant drug
10) admission due to liver disease
11) micro RNA
12) microbiota
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035510
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
