UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042929 |
|---|---|
| Receipt number | R000048852 |
| Scientific Title | Multicenter, single-arm prospective observational study |
| Date of disclosure of the study information | 2021/02/28 |
| Last modified on | 2021/01/06 19:42:28 |
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Basic information
Public title
Multicenter prospective cohort study to evaluate renal tubular function after switching from ETV to TAF
- Niigata University study group -
Acronym
Multicenter prospective cohort study to evaluate renal tubular function after switching from ETV to TAF
- Niigata University study group -
Scientific Title
Multicenter, single-arm prospective observational study
Scientific Title:Acronym
Multicenter, single-arm prospective observational study
Region
| Japan |
Condition
Condition
Patients with chronic hepatitis B in currently active treatment with ETV for more than 1year
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate changes in efficacy, safety, and tolerability after switching from ETV to TAF for
patients with chronic hepatitis B in active treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in rate of virus suppression on 24 weeks after switching from ETV to TAF.
Key secondary outcomes
Change in renal tubular function on 12 weeks after switching from ETV to TAF
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis B in currently active treatment with ETV for more than 1year
Key exclusion criteria
Patients who have a history of hypersensitivity to TAF
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Terai |
Organization
Niigata University
Division name
Division of gastroenterology
Zip code
951-8510
Address
Niigata Japan
TEL
0252272207
hiroteruk@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroteru |
| Middle name | Kamimura |
| Last name | Kamimura |
Organization
Niigata University
Division name
Division of gastroenterology
Zip code
9518510
Address
Niigata Japan
TEL
0252272207
Homepage URL
hiroteruk@med.niigata-u.ac.jp
Sponsor or person
Institute
niigata university
Institute
Department
Personal name
Funding Source
Organization
niigata universuty
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NiigataUniversity
Address
Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata Japan
Tel
0252272207
hiroteruk@med.niigata-u.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
| 2021 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation test
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048852
