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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030661
Receipt No. R000035006
Scientific Title The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs
Date of disclosure of the study information 2018/01/20
Last modified on 2019/08/23

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Basic information
Public title The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs
Acronym TAF for chronic HBV infection
Scientific Title The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs
Scientific Title:Acronym TAF for chronic HBV infection
Region
Japan

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

Objectives
Narrative objectives1 To clarify the long-term usefulness and safety of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate (TAF) in patients with chronic HBV infection treated with other NAs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HBs antigen level and frequency of occurrence of adverse events (including abnormal clinical laboratory tests) at 5 years after the initiation of TAF administration.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switch nucleoside/nucleotide analogue to
TAF and observe for 5 years
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 (1) Patients with chronic HBV infection who have been treated with entecavir or combination of adefovir and lamivudine for more than 1 year.
(2) HBs antigen is more than 80 IU/mL.
(3) Over 20 years old.
Key exclusion criteria (1) Patients who is taking immunosuppressive agents
(2) Patients who is infected also with HIV
(3) Patients treated with contraindicated drug together with TAF.
(4) Patients who is considered inappropriate for this study by doctors in attendance
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name MOCHIDA
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code 350-0495
Address 38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL 049-276-1198
Email smochida@saitama-med.ac.jp

Public contact
Name of contact person
1st name Yoshihito
Middle name
Last name UCHIDA
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code 350-0495
Address 38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL 049-276-1198
Homepage URL
Email y_uchida@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
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 the Institutional Review Board of Saitama Medical University Hospital
Address 38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
Tel 049-276-1354
Email hirb@saitama-med.ac.jp

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 01 Month 20 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
2018 Year 01 Month 20 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 02 Day
Last modified on
2019 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035006

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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