UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012423 |
|---|---|
| Receipt number | R000014533 |
| Scientific Title | Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2019/08/02 15:41:12 |
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Basic information
Public title
Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues
Acronym
Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues
Scientific Title
Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues
Scientific Title:Acronym
Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Antiviral therapy on patients with chronic hepatitis B aims to suppress the incidence of developing hepatocellular carcinoma (HCC), and nucleos(t)de analogues (NAs) have been generally used in Japan. Although NAs exert antiviral effects through inhibition of HBV DNA reverse transcriptase, they have no effect on cccDNA present in hepatocyte nuclei, so the suppressive effects of NAs against HCC development might be inadequate. The aim of this study is to investigate association between serum HBV markers, including HBV DNA, HBs antigen or HB core-related antigen, and the incidence of HCC in patients with chronic hepatitis B receiving NAs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the cumulative incidence of hepatocellular carcinoma
decline of HB surface antigen, loss of HB surface antigen
decline of HB core-related antigen
suppression of HBV DNA (<2.6LC/mL)
ALT normalization
HBe antigen seroconversion (applied in patients positive for HBe antigen att baseline)
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
patients with chronic hepatits B treated with nucleos(t)ide analogues for more than 1 year
Key exclusion criteria
under age of 20
coinfection with HCV / HDV / HIV
coexistence with other chronic liver disease
pregnant or breast-feeding women
coexistence with severe disease of other organs, or immunodeficiency
patients found to be inadequate by their doctors
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Yamada |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3621
Homepage URL
ryo726@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine,
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Itami City Hospital
Higashiosaka City Central Hospital
Otemae Hospital
Sumitomo Hospital
Nishinomiya Municipal Central Hospital
National Hospital Organization Osaka National Hospital
Osaka Police Hospital
NTT West Osaka Hospital
Kansai Rosai Hospital
Osaka Koseinenkin Hospital
Yao Municipal Hospital
Suita Municipal Hospital
Ashiya Municipal Hospital
Saiseikai Senri Hospital
Hyogo Prefectural Nishinomiya Hospital
National Hospital Organization Osaka Minami Medical Center
Toyonaka Municipal Hospital
Osaka Medical Center for Cancer and Cardiovascular Diseases
Minoh City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
| 2013 | Year | 11 | Month | 27 | 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
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study / retrospective study
Management information
Registered date
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014533
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