UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031754 |
|---|---|
| Receipt number | R000036220 |
| Scientific Title | Efficacy and safty of tenofovir alafenamide treatment swithed from entecavir in patinets with chronic hepatitis B. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/04/10 20:07:56 |
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Basic information
Public title
Efficacy and safty of tenofovir alafenamide treatment swithed from entecavir in patinets with chronic hepatitis B.
Acronym
Efficacy and safty of tenofovir alafenamide swithed from entecavir.
Scientific Title
Efficacy and safty of tenofovir alafenamide treatment swithed from entecavir in patinets with chronic hepatitis B.
Scientific Title:Acronym
Efficacy and safty of tenofovir alafenamide swithed from entecavir.
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy (HBsAg decrease) and safety of tenofovir alafenamide switched from entecavir in patients with chronic hepatitis B
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The mean and median decline in HBsAg level of tenofovir alafenamide at 1, 2 , 3 years after randomization.
Key secondary outcomes
HBsAg and HBeAg seloclearance rates at 1, 2 , 3 years after randomization.
Rates of HBsAg < 100 IU/mL amd < 1000 IU/mL and HBV DNA elevation rates.
Ccr, eGFR, Urine and serum phosphorus
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tenofovir alafenamide switched from entecavir in patinets with low HBV DNA level.
treatment period; 3 years
Tenofovir alafenamide 25mg/day
interventin time: one
Interventions/Control_2
control group; entecavir continued.
entecavir 0.5mg/day
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
entecavir treatment period; more than 1 year
more than 20 years old
HBsAg positive
HBV DNA; less than 3.0 log IU/mL (more than 1 year)
Key exclusion criteria
Ccr less than 15 mL/min
patients who can't have informed consent.
Doctors jugde inadequate patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumitaka |
| Middle name | |
| Last name | Suzuki |
Organization
Federation of National Public Service Personnel Mutual Aid Associations
Toranomon Hospital
Toranomon Hospital Kajigaya
Division name
Department of Hepatology
Zip code
2138587
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa
TEL
0448775111
fumitakas@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Fumitaka |
| Middle name | |
| Last name | Suzuki |
Organization
Department of Hepatology
Division name
Department of Hepatology
Zip code
2138587
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa
TEL
0448775111
Homepage URL
fumitakas@toranomon.gr.jp
Sponsor or person
Institute
Federation of National Public Service Personnel Mutual Aid Associations
Toranomon Hospital
Toranomon Hospital Kajigaya
Department of Hepatology
Institute
Department
Personal name
Funding Source
Organization
Federation of National Public Service Personnel Mutual Aid Associations
Toranomon Hospital
Toranomon Hospital Kajigaya
Department of Hepatology
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
Toranomon Hospital IRB
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
0335881111
chikenjimukyoku@toranomon.gr.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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000036220
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000036220
Number of participants that the trial has enrolled
0
Results
This clinical trail was discontinued.
Results date posted
| 2020 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This clinical trail was discontinued.
Participant flow
This clinical trail was discontinued.
Adverse events
This clinical trail was discontinued.
Outcome measures
This clinical trail was discontinued.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 20 | 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 | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036220
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/10 | ETVvsTDF 試験計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/04/10 | ETV TDF data.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/10 | ETV TDF data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/36220
