UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032728 |
|---|---|
| Receipt number | R000036878 |
| Scientific Title | Non-randomized control study of the evaluation for the switching entecavir to tenofovir alafenamide fumarate in patients with chronic HBV infection |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2023/11/29 10:19:29 |
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Basic information
Public title
Non-randomized control study of the evaluation for the switching entecavir to tenofovir alafenamide fumarate in patients with chronic HBV infection
Acronym
Non-randomized control study of the evaluation for the switching entecavir to tenofovir alafenamide fumarate
Scientific Title
Non-randomized control study of the evaluation for the switching entecavir to tenofovir alafenamide fumarate in patients with chronic HBV infection
Scientific Title:Acronym
Non-randomized control study of the evaluation for the switching entecavir to tenofovir alafenamide fumarate
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 evaluate with the efficacy and safety
of the switching entecavir to tenofovir alafenamide fumarate in patients with chronic HBV infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate of HBsAg
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch oral administration of entecavir to tenofovir alafenamide fumarate.
Interventions/Control_2
keep on administration of entecavir
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 and under treatment by nucleoside analogue
Key exclusion criteria
1) Patients whose CCr is lower than 15ml/min
2) Patients who are pregnant or have possibilities of pregnancy
3) Patients who are infected HIV or HCV
4) Patients who are considered to be inappropriate for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruki Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruki Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
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 | 05 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 04 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036878
