UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection
Acronym	Tenofovir study in NA-treated patients with HBV
Scientific Title	Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection
Scientific Title:Acronym	Tenofovir study in NA-treated patients with HBV
Region	Japan

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

Objectives
Narrative objectives1	In this randomized control study, the entecavir-treated patients with chronic HBV infection are assigned to two groups: tenofovir-switch group and entecavir-continue group. Then we investigate the virological effects, the emergence rate of drug-resistant mutants, and the biochemical effects. The lamivudine/adefovir-teated patietns are assinged to two groups: lamivudine/tenofovir group and tenofovir alone group. Then we compare the efficacies as above.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The decline of HBsAg 2 years after the enrollment
Key secondary outcomes	The negativity of HBV DNA and HBeAg, and the normalization of ALT

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switch to tenofovir 300 mg/day in patients treated with entecavir 0.5 mg/day and observe for 2 years
Interventions/Control_2	Continue entecavir 0.5 mg/day in patients treated with entecavir and observe for 2 years
Interventions/Control_3	Switch to lamivudine 100 mg/day and tenofovir 300 mg/day in patients treated with lamivudine and adefovir 10 mg/day and observe for 2 years
Interventions/Control_4	Switch to tenofovir 300 mg/day alone in patients treated with lamivudine 100 mg/day and adefovir 10 mg/day and observe for 2 years
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) HBV DNA is less than 4.0 log copies/ml (3) The liver disease is chronic hepatitis or compensated liver cirrhosis (up to Clid-Pugh grade A)
Key exclusion criteria	(1) Patients who is received interferon treatments (2) Patients who is taking immunosuppressive agents (3) Patients who have present or past hepatocellular carcinoma, or other malignant diseases (4) Patients who have decompensated liver cirrhosis (5) Patients who have renal dysfunction (eGFR is less than 50 ml/min/1.72m2) (6) Patients who have low serum phosphorus (less than 2.5 mg/dl) (7) Patients who are pregnant or have possibility of pregnancy (8) Breast-feeding patients (9) Patients who is infected also with HIV or HCV (10) Patients who is participating other studies (11) Patients who is considered inappropriate for this study by doctors in attendance
Target sample size	180

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

Public contact
Name of contact person	1st name Middle name Last name Eiji Kakazu
Organization	Tohoku University Hospital
Division name	Division of Gastroenterology
Zip code
Address	1-1 Seiryo, Aoba-ku, Sendai, Miyagi
TEL	022-717-7171
Homepage URL
Email	eijikakazu@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Self funding
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）、大曲厚生医療センター（秋田県）、岩手県立中央病院（岩手県）、気仙沼市立病院（宮城県）、石巻市立病院（宮城県）、東北労災病院（宮城県）、仙台赤十字病院（宮城県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 01 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	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
Date of IRB	2016 Year 04 Month 15 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2019 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	2016 Year 04 Month 17 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=R000025301