UMIN-CTR Clinical Trial

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
Email	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
Email	ryo726@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014533