UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of TAF prophylactic administration for HBV reactivation hepatitis during immunosuppressive or anti-tumor therap
Title of the study (Brief title)	TAF for prevention of HBV reactivation
Region	Japan

Condition
Condition	Patients with current or previous HBV infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of TAF prophylactic administration for patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of prevention to HBV reactivation hepatitis at 1 year after initiation of TAF
Key secondary outcomes	1) The rate of prevention to HBV reactivation hepatitis at 2 years after initiation of TAF 2) Disappear of serum HBV-DNA, at 1 years after treatment initiation 3) Safety of TAF administration 4) The change of serum HBs antigen titer during the therapy

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
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	Inclusion criteria 1) Patients aged 20 years or older at the time of consent 2) Patients who received an adequate explanation prior to the study and provided written consent for participation in the study 3) (i) Patients who are HBs Ag positive and/or HBV-DNA positive and receive TAF administration for preventing HBV reactivation, ahead of anti-tumor therapy (for solid tumor, malignant lymphoma or leukemia ) or immunosuppressive therapy (for auto immune disease (RA, SLE, nephrosis syndrome, et al),. (ii) Patients who does not meet the criteria described above (i) with previous HBV infection who experience HBV reactivation during anti-tumor therapy or immunosuppressive therapy and receive TAF administration for preventing HBV reactivation hepatitis.
Key exclusion criteria	1) Patients with a past history of hypersensitivity to TAF 2) Patients with serious liver dysfunction (Child-Pugh Class B or C) 3) Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia) 4) Liver transplantation 5) Patients who are not expected to be survived more than 12 month by the primary physician. 6) Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size	250

Research contact person
Name of lead principal investigator	Goki Suda
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-2111
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	Goki Suda
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-2111
Homepage URL
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	Hokkaido university
Institute
Department

Funding Source
Organization	Gilead Sciences, Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2018 Year 11 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 28 Day
Anticipated trial start date	2018 Year 07 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	Viral factors Peripheral blood tests Liver function Biochemistry Fibrosis markers Glucose Blood coagulation PT INR Measurement of liver stiffness CT or US

Management information
Registered date	2018 Year 11 Month 28 Day
Last modified on	2018 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039955