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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029099
Receipt No. R000033283
Scientific Title Effectiveness and safety of tenofovir alafenamide for chronic hepatitis B patients
Date of disclosure of the study information 2017/11/01
Last modified on 2017/09/12

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Basic information
Public title Effectiveness and safety of tenofovir alafenamide for chronic hepatitis B patients
Acronym Effectiveness and safety of TAF
Scientific Title Effectiveness and safety of tenofovir alafenamide for chronic hepatitis B patients
Scientific Title:Acronym Effectiveness and safety of TAF
Region
Japan

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

Objectives
Narrative objectives1 effectiveness
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Decline of HBsAg
Seroclearance rate of HBsAg
Key secondary outcomes Normalized rate of ALT
Undetectable rate of HBV DNA and HBeAg
Changes of serum creatinine, eGFR, serum phosphate, urinary protein, urinary NAG, urinary beta-2-microglobrin, bone density

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 Tenofovir alafenamide 25mg daily or alternate day
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 Chronic hepatitis B or cirrhosis
Key exclusion criteria insufficient of clinical data
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumitaka Suzuki
Organization Toranomon Hospital
Division name Hepatology
Zip code
Address 2-2 Toranomon Minato-ku Tokyo
TEL 03-3588-1111
Email fumitakas@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Hosaka
Organization Toranomon branch Hospital
Division name Hepatology
Zip code
Address 1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL 044-877-5111
Homepage URL
Email hosa-p@toranomon.gr.jp

Sponsor
Institute Toranomon branch 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)

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
2017 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 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=R000033283

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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