UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016982 |
|---|---|
| Receipt number | R000019707 |
| Scientific Title | A multicenter prospective cohort study on hepatocarcinogenesis in patients with chronic hepatitis C after sustained virological response to direct acting antivirals |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2018/10/02 13:24:53 |
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Basic information
Public title
A multicenter prospective cohort study on hepatocarcinogenesis in patients with chronic hepatitis C after sustained virological response to direct acting antivirals
Acronym
A prospective cohort study on hepatocarcinogenesis in patients with chronic hepatitis C after sustained virological response
Scientific Title
A multicenter prospective cohort study on hepatocarcinogenesis in patients with chronic hepatitis C after sustained virological response to direct acting antivirals
Scientific Title:Acronym
A prospective cohort study on hepatocarcinogenesis in patients with chronic hepatitis C after sustained virological response
Region
| Japan |
Condition
Condition
Chronic hepatitis C after sustained virological response
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the preventive effect of direct acting antivirals on hepatocarcinogenesis in patients with chronic hepatitis C after sustained virological response.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free survival
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
1) Patients with chronic hepatitis C or compensated cirrhosis who achieved sustained virological response to either treatments as follows; a) Direct acting antivirals in combination with peginterferon and rivabirin; b) Interferon-free regimen with direct acting antivirals.
2) Patients without history of hepatocellular carcinoma.
Key exclusion criteria
1) Patients with Child-Pugh class C.
2) HBsAg-positive patients.
3) Patients who have malignant neoplasm.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Mizuta |
Organization
Imari Arita Kyoritsu Hospital
Division name
Internal Medicine
Zip code
Address
860 Ninose-Ko Arita-cho, Nishimatsuura, Saga, Japan
TEL
0955-46-2121
mizuta1221@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Kawaguchi |
Organization
Saga-ken Medical Centre Koseikan
Division name
Hepatobiliary-pancreatology
Zip code
Address
400 Nakabaru Kase-machi, Saga, Japan
TEL
0952-24-2171
Homepage URL
kawaguy222@gmail.com
Sponsor or person
Institute
Saga Study Group of Liver Diseases
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We prospectively observe patients with sustained virological response (SVR) to direct acting antivirals (DAAs) and compare between cohort A and B regarding hepatocarcinogenesis.
Cohort A: Patients who achieved SVR after DAAs combined with peginterferon and ribavirin.
Cohort B: Patients who achieved SVR after interferon-free regimen using DAAs.
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019707
