UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between tenofovir alafenamide and entecavir in the efficacy and safety for chronic hepatitis B patients treatment.
Title of the study (Brief title)	Comparison between tenofovir alafenamide and entecavir in the efficacy and safety for chronic hepatitis B patients treatment.
Region	Japan

Condition
Condition	patients with hepatitis B virus genotype C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to compare TAF and entecavir in the efficacy and safety for chronic hepatitis B patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The decrease of cccDNA levels in the liver at 48 weeks after the treatment.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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 alafenamide
Interventions/Control_2	entecavir
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with hepatitis B virus genotype C
Key exclusion criteria	Patients with the past history of hypersensitivity against biologicals such as vaccine. Patients using Sho-saiko-to at present Autoimmune disease patients Patients with the past history of hypersensitivity against TAF and/or Entecavir
Target sample size	60

Research contact person
Name of lead principal investigator	Naoshi Nishida
Organization	Kindai University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2, Onho-Higashi, Osaka-Sayama, Osaka, 589-8511
TEL	072-366-0221
Email	naoshi@med.kindai.ac.jp

Public contact
Name of contact person	Satoru Hagiwara
Organization	Kindai University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2, Onho-Higashi, Osaka-Sayama, Osaka, 589-8511
TEL	072-366-0221
Homepage URL
Email	hagi-318@hotmail.co.jp

Sponsor
Institute	Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 08 Day
Anticipated trial start date	2017 Year 04 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	2017 Year 03 Month 08 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030393