UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030661 |
|---|---|
| Receipt number | 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 | 2020/01/04 14:30:29 |
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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
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
y_uchida@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
70
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
| 2020 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
