UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir
Acronym	Randomized control study to evaluate efficacy and safety of TAF for chronically HBV-infected patients treated with ETV
Scientific Title	Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir
Scientific Title:Acronym	Randomized control study to evaluate efficacy and safety of TAF for chronically HBV-infected patients treated with ETV
Region	Japan

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

Objectives
Narrative objectives1	The objective of this randomized control study is to evaluate efficacy and safety of switch from entacavir to tenofovir alafenamide fumarate (TAF) in chronically hepatitis B virus (HBV)-infected patients whose HBV DNA levels are relatively controlled. This study evaluates anti-viral effects, frequencies of drug resistant virus, and biochemical responses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change and negativity rate of HBsAg in every year during 4-year observation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switch oral administration of entecavir to tenofovir alafenamide fumarate (25 mg/day) and continue for 4 years.
Interventions/Control_2	Continue entecavir for 4 years.
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) Chronically HBV-infected patients who have been treated with entecavir for more than 1 year and are positive for HBsAg (2) Serum HBV DNA is less than 3.3 log IU/ml (3) chronic hepatitis or compensated liver cirrhosis (up to Child-Pugh grade A) (4) Age is 20 years old or older (no upper limit, at the registration) (5) Both male and female
Key exclusion criteria	(1) Patients who are treated with interferon (2) Patients who are treated with immunosuppressants (3) Patients who have or had hepatocellular carcinoma, or other malignancies (4) Patients who have decompensated liver cirrhosis (5) Patients whose phosphorus is lower than 2.5 mg/dl (6) Patients who are pregnant or have possibilities of pregnancy (7) Patients who are breastfeeding (8) Patients who are infected HIV or HCV (9) Patients who are participating other researches (10) Patients who are considered to be inappropriate for this study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Inoue
Organization	Tohoku University Hospital
Division name	Department of Gastroenterology
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7171
Email	jinoue-drgn@umin.net

Public contact
Name of contact person	1st name Middle name Last name Masashi Ninomiya
Organization	Tohoku University Hospital
Division name	Department of Gastroenterology
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7171
Homepage URL
Email	m-nino5@hello.odn.ne.jp

Sponsor
Institute	Department of Gastroenterology, Tohoku University Hospital
Institute
Department

Funding Source
Organization	Self-funding (Department of Gastroenterology, Tohoku University Hospital)
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
Address
Tel
Email

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	東北大学病院（宮城県）、石巻赤十字病院（宮城県）、東北労災病院（宮城県）、仙台医療センター（宮城県）、仙台市立病院（宮城県）、みやぎ県南中核病院（宮城県）、いわき市立総合磐城共立病院（福島県）、岩手県立磐井病院（岩手県）、LCクリニック（宮城県）、坂総合病院（宮城県）、JR仙台病院（宮城県）、仙台赤十字病院（宮城県）、東北医科薬科大学病院（宮城県）、登米市立登米市民病院（宮城県）、大崎市民病院（宮城県）、岩手県立中央病院（岩手県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 11 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	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 27 Day
Date of IRB	2018 Year 10 Month 18 Day
Anticipated trial start date	2018 Year 04 Month 16 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

Management information
Registered date	2018 Year 04 Month 11 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036725