UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial
Title of the study (Brief title)	Switching from entecavir to tenofovir for CHB patients with sustained viral supression
Region	Japan

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

Objectives
Narrative objectives1	Exploring the reduction of hepatitis B surface antigen and the safety by switching from entecavir to tenofovir for patients who were treated with entecavir for more than one year and achieved sustained viral supression (HBV DNA levels < 3.0 logcopies/mL)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of patients who achieve the reduction of hepatitis surface antigen more than 0.5 log IU/mL for three years
Key secondary outcomes	1) The rates of negativity of hepatitis B e antigen for three years 2) The rates of negativity of hepatitis B surface antigen and achieving below 100 IU/mL or 1000 IU/mL of hepatitis B surface antigen levels for three years Predictive factors of the reduction of hepatitis B surface antigen 3) The rates of viral breakthrough for three years 4) The chenges of serum creatinine and phosphate for three years

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	Tenofovir disoproxil fumarate 300mg/day daily treatment period: 3 yaers
Interventions/Control_2	Entecavir 0.5mg/day daily treatment period: 3 yaers
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients treated with entecavir for more than one year Inclusion criteria as following; 1) Hepatits B surface antigen positive 2) HBV DNA levels < 3.0 log copies/mL for more than one year 3) Absence of renal impairment (serum creatinine levels <1.1mg/dL, eGFR >60 ml/min/1.73m2 and creatinine clearance >50ml/min) 4) Absence of hypophosphatemia (serum phosphate >2.8 mg/dL)
Key exclusion criteria	1) Hypersensitivity for tenofovir 2) Presence of renal impairment 3) Presence of hypophosphatemia 4) Poorly-controlled diabetes 5) Poorly-controlled hypertension 6) History of hepatocellular carcinoma 7) Ineligible patients by atending physician
Target sample size	100

Research contact person
Name of lead principal investigator	Hiromitsu Kumada
Organization	Toranomon Hospital
Division name	Hepatology
Address	2-2-2 Toranomon Minato-ku Tokyo
TEL	03-3588-1111
Email	kumahiro@toranomon.gr.jp

Public contact
Name of contact person	Tetsuya Hosaka
Organization	Toranomon Hospital
Division name	Hepatology
Address	2-2-2 Toranomon Minato-ku Tokyo
TEL	044-877-5111
Homepage URL
Email	hosa-p@toranomon.gr.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Toranomon Hospital
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	虎の門病院(東京都)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 08 Month 01 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

Management information
Registered date	2015 Year 07 Month 24 Day
Last modified on	2017 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021308