UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027342 |
|---|---|
| Receipt number | R000031332 |
| Scientific Title | Development of hepatocellular carcinoma after hepatitis C virus eradication in interferon-free direct-acting antivirals |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2023/05/20 09:36:10 |
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Basic information
Public title
Development of hepatocellular carcinoma after hepatitis C virus eradication in interferon-free direct-acting antivirals
Acronym
Development of hepatocellular carcinoma after direct-acting antivirals
Scientific Title
Development of hepatocellular carcinoma after hepatitis C virus eradication in interferon-free direct-acting antivirals
Scientific Title:Acronym
Development of hepatocellular carcinoma after direct-acting antivirals
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the risk of HCC among patients with chronic HCV infection, including compensated cirrhosis and previous HCC, following the achievement sustained viral response by DAA treatment.
Basic objectives2
Others
Basic objectives -Others
To evaluate the baseline and on-treatment factors associated with HCC development.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of the HCC development after DAA treatment.
Key secondary outcomes
Factors associated with HCC development.
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) chronic hepatitis C patients
Key exclusion criteria
(1) under age 20 at the initiation of treatment
(2) decompensated cirrhosis with Child-Pugh B or C
(3) concomitant human immunodeficiency virus or hepatitis B virus infection
(4) excessive active alcohol consumption
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
e.ogawa.a65@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
Homepage URL
e.ogawa.a65@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
Tel
0926425909
inenaga.tomomi.503@m.kyushu-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
| 2017 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/apt.14380
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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter, observational cohort study analyzed the data of consecutive patients who were enrolled for treatment with an interferon-free DAA regimen for chronic HCV infection from June 2015.
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031332
| 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 |
