UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective cohort study to evaluate renal tubular function after switching from ETV to TAF - Niigata University study group -
Acronym	Multicenter prospective cohort study to evaluate renal tubular function after switching from ETV to TAF - Niigata University study group -
Scientific Title	Multicenter, single-arm prospective observational study
Scientific Title:Acronym	Multicenter, single-arm prospective observational study
Region	Japan

Condition
Condition	Patients with chronic hepatitis B in currently active treatment with ETV for more than 1year
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate changes in efficacy, safety, and tolerability after switching from ETV to TAF for patients with chronic hepatitis B in active treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in rate of virus suppression on 24 weeks after switching from ETV to TAF.
Key secondary outcomes	Change in renal tubular function on 12 weeks after switching from ETV to TAF

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis B in currently active treatment with ETV for more than 1year
Key exclusion criteria	Patients who have a history of hypersensitivity to TAF
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shuji Middle name Last name Terai
Organization	Niigata University
Division name	Division of gastroenterology
Zip code	951-8510
Address	Niigata Japan
TEL	0252272207
Email	hiroteruk@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Hiroteru Middle name Kamimura Last name Kamimura
Organization	Niigata University
Division name	Division of gastroenterology
Zip code	9518510
Address	Niigata Japan
TEL	0252272207
Homepage URL
Email	hiroteruk@med.niigata-u.ac.jp

Sponsor
Institute	niigata university
Institute
Department

Funding Source
Organization	niigata universuty
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NiigataUniversity
Address	Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata Japan
Tel	0252272207
Email	hiroteruk@med.niigata-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	2021 Year 02 Month 28 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	2020 Year 08 Month 01 Day
Date of IRB	2019 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observation test

Management information
Registered date	2021 Year 01 Month 06 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048852