UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034696 |
|---|---|
| Receipt number | R000039553 |
| Scientific Title | Treatment outcome and long-term prognosis of antiviral therapy for chronic B or C infection-A multicenter cohort study |
| Date of disclosure of the study information | 2018/10/30 |
| Last modified on | 2023/03/28 09:23:13 |
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Basic information
Public title
Treatment outcome and long-term prognosis of antiviral therapy for chronic B or C infection-A multicenter cohort study
Acronym
Treatment outcome of antiviral therapy for chronic B or C infection
Scientific Title
Treatment outcome and long-term prognosis of antiviral therapy for chronic B or C infection-A multicenter cohort study
Scientific Title:Acronym
Treatment outcome of antiviral therapy for chronic B or C infection
Region
| Japan |
Condition
Condition
Chronic hepatitis B or C
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate the virological effect and the development of hepatocellular carcinoma in the long-term after the antiviral therapy for patients with chronoic HBV or HCV infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Virological effect and the development of hepatocellular carcinoma after the antiviral therapy
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) HBV: Patients with receiving nucleos(t)ide analogue treatment
(2) HCV: Patients with past history of DAA treatment
Key exclusion criteria
Any other clinical conditions that, in the opinion of the investigator, would make the subject unsuitable or unable to comply with any of the study procedures
Target sample size
5000
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 Hospital
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
Kyushu University
Address
3-1-1 Maidashi Higashi-ku
Tel
0926425909
e.ogawa.a65@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
| 2018 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | 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
Multicenter obsevational cohort study
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039553
| Research Plan | |
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| 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 |
