UMIN-CTR Clinical Trial

Basic information
Public title	The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs
Acronym	TAF for chronic HBV infection
Scientific Title	The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs
Scientific Title:Acronym	TAF for chronic HBV infection
Region	Japan

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

Objectives
Narrative objectives1	To clarify the long-term usefulness and safety of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate (TAF) in patients with chronic HBV infection treated with other NAs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HBs antigen level and frequency of occurrence of adverse events (including abnormal clinical laboratory tests) at 5 years after the initiation of TAF administration.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switch nucleoside/nucleotide analogue to TAF and observe for 5 years
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 with chronic HBV infection who have been treated with entecavir or combination of adefovir and lamivudine for more than 1 year. (2) HBs antigen is more than 80 IU/mL. (3) Over 20 years old.
Key exclusion criteria	(1) Patients who is taking immunosuppressive agents (2) Patients who is infected also with HIV (3) Patients treated with contraindicated drug together with TAF. (4) Patients who is considered inappropriate for this study by doctors in attendance
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name MOCHIDA
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	350-0495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL	049-276-1198
Email	smochida@saitama-med.ac.jp

Public contact
Name of contact person	1st name Yoshihito Middle name Last name UCHIDA
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	350-0495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL	049-276-1198
Homepage URL
Email	y_uchida@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the Institutional Review Board of Saitama Medical University Hospital
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
Tel	049-276-1354
Email	hirb@saitama-med.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	2018 Year 01 Month 20 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	70
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	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 20 Day
Date of IRB	2018 Year 01 Month 20 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 02 Day
Last modified on	2020 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035006