UMIN-CTR Clinical Trial

Basic information
Public title	Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B
Acronym	Effectiveness for switiching to tenofovir alafenamide
Scientific Title	Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B
Scientific Title:Acronym	Effectiveness for switiching to tenofovir alafenamide
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy, safety, and tolerability after switching from other nucleos(t)ide analogues to TAF for nucleos(t)ide analogue-experienced Japanese patients with chronic hepatitis B
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Proportion of patients with virological response (HBV DNA level <2.1 log copies/mL) at weeks 24, 48, 96, 120 and 144 after switching from other nucleos(t)ide analogues to TAF
Key secondary outcomes	1.Changes from the baseline in hepatitis surface antigen levels 2.Changes from the baseline in serum alanine aminotransferase 3.Changes from the baseline in estimated glomerular filtration rate and urine beta-2 microglobulinuria 4.Changes from the baseline in albuminuria 5.Changes in spine-and hip-bone mineral density

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
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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 hepatitis B and under treatment by nucleos(t)ide analogue(s) (lamivudine (LMV), adefovir dipivoxil (ADV), entecavir (ETV), and tenofovir disoproxil fumarate (TDF)), including compensated cirrhosis. 2.Patients with stable and well controlled hypertension, diabetes mellitus, heart diseases, CKD or risk of CKD (eGFR <60), and other patients whom Dr. consider appropriate to switch.
Key exclusion criteria	1.Patients with decompensated cirrhosis 2.Patients with co-infection of hepatitis C virus 3.Patients with co-infection of human immunodeficiency virus 4.Patients with stable estimated glomerular filtration rate <15 mL/min/1.73 m2 5.Patients with albumin <30 g/L and platelets <30,000 6.Patients with autoimmune hepatitis 7.Constant heavy alcohol drinkers (converted to ethanol over 60 g/day) 8.Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding 9.Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norihiro Furusyo
Organization	Kyushu University Hospital
Division name	Kyushu University Liver Disease Study (KULDS)
Zip code
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Eiichi Ogawa
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Zip code
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Homepage URL
Email	eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Gilead Sciences K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 26 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2018 Year 03 Month 26 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036427

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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