UMIN-CTR Clinical Trial

Basic information
Public title	The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Acronym	The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Scientific Title	The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Scientific Title:Acronym	The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Region	Japan

Condition
Condition	Chronic hepatitis B virus infected patient
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To analyze the degree of HBsAg decline after administration of nucleos(t)ide analugues, and to investigate the associated factor of HBsAg decline
Basic objectives2	Others
Basic objectives -Others	To analyze the degree of HBsAg decline after administration of nucleos(t)ide analugues, and to investigate the associated factor of HBsAg decline
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The degree of HBV-DNA and HBsAg decline 1 year after administration of nucleos(t)ide analugues
Key secondary outcomes	1. The degree of HBV-DNA and HBsAg decline 3, 5, 10 years after administration of nucleos(t)ide analugues 2. Relevalence between IL28B SNPs and HBsAg decline 3. Relevalence between serum IFN-lambda3 and HBsAg decline 4. Relevalence between emergence of resistant associated variant and antiviral effect 5. efficacy of improvement of hepatic fibrosis 6. efficacy of improvement of AST/ALT

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 who are 20 years of age or older at the time of obtaining informed consent 2. Patients who are informed and have provided written informed consent to participate in the study prior to study initiation 3. Patients with chronic HBV who do not meet any of the following exclusion criteria 4. Patients receiving nucleos(t)ide analogues or plan to be treated with nucleos(t)ide analogues
Key exclusion criteria	1. Patients with difficult to manage cardiac disease 2. Patients who have a history of allergic reaction by nucleos(t)ide analogues 3. Patients treated with contraindicated drug together with nucleos(t)ide analogues 4. Patients by whom doctor in charge has determined to be inappropriate as a subject 5. Patients by whom principal investigator has determined to be inappropriate as a subject
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Goki Middle name Last name Suda
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	060-8648
Address	Kita15, Nishi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL	011-716-1161
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Goki Middle name Last name Suda
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	060-8648
Address	Kita15, Nishi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL	011-716-1161
Homepage URL	http://halo.med.hokudai.ac.jp/group/-/hepatology/
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 06 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	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 15 Day
Date of IRB	2017 Year 06 Month 14 Day
Anticipated trial start date	2017 Year 06 Month 21 Day
Last follow-up date	2033 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	an observational study with CHB treated with NAs

Management information
Registered date	2017 Year 10 Month 05 Day
Last modified on	2022 Year 03 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033638