UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dynamics of HBV markers during nucleotide analogue treatment
Title of the study (Brief title)	Dynamics of HBV markers during nucleotide analogue treatment
Region	Japan

Condition
Condition	HBV carrier
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the dynamics of HBV markers during NA treatment
Basic objectives2	Others
Basic objectives -Others	HBsAg HBcrAg
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of patients who showed low HBsAg and HBcrAg during NA treatment
Key secondary outcomes	Predicting factors

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	HBV carriers with NA treatment
Key exclusion criteria	HBVDNA breakthrough
Target sample size	70

Research contact person
Name of lead principal investigator	Makoto Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Japan
TEL	043-226-2083
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	Makoto Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Japan
TEL	043-226-2083
Homepage URL
Email	araim-cib@umin.ac.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 02 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 23 Day
Anticipated trial start date	2017 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective analysis

Management information
Registered date	2017 Year 02 Month 07 Day
Last modified on	2018 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029930