UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032201 |
|---|---|
| Receipt number | R000036725 |
| Scientific Title | Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir |
| Date of disclosure of the study information | 2018/04/11 |
| Last modified on | 2021/01/26 18:22:39 |
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Basic information
Public title
Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir
Acronym
Randomized control study to evaluate efficacy and safety of TAF for chronically HBV-infected patients treated with ETV
Scientific Title
Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir
Scientific Title:Acronym
Randomized control study to evaluate efficacy and safety of TAF for chronically HBV-infected patients treated with ETV
Region
| Japan |
Condition
Condition
chronic hepatitis B virus infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this randomized control study is to evaluate efficacy and safety of switch from entacavir to tenofovir alafenamide fumarate (TAF) in chronically hepatitis B virus (HBV)-infected patients whose HBV DNA levels are relatively controlled. This study evaluates anti-viral effects, frequencies of drug resistant virus, and biochemical responses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change and negativity rate of HBsAg in every year during 4-year observation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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 (25 mg/day) and continue for 4 years.
Interventions/Control_2
Continue entecavir for 4 years.
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) Chronically HBV-infected patients who have been treated with entecavir for more than 1 year and are positive for HBsAg
(2) Serum HBV DNA is less than 3.3 log IU/ml
(3) chronic hepatitis or compensated liver cirrhosis (up to Child-Pugh grade A)
(4) Age is 20 years old or older (no upper limit, at the registration)
(5) Both male and female
Key exclusion criteria
(1) Patients who are treated with interferon
(2) Patients who are treated with immunosuppressants
(3) Patients who have or had hepatocellular carcinoma, or other malignancies
(4) Patients who have decompensated liver cirrhosis
(5) Patients whose phosphorus is lower than 2.5 mg/dl
(6) Patients who are pregnant or have possibilities of pregnancy
(7) Patients who are breastfeeding
(8) Patients who are infected HIV or HCV
(9) Patients who are participating other researches
(10) Patients who are considered to be inappropriate for this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Inoue |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7171
jinoue-drgn@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Ninomiya |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7171
Homepage URL
m-nino5@hello.odn.ne.jp
Sponsor or person
Institute
Department of Gastroenterology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding (Department of Gastroenterology, Tohoku University 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
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
東北大学病院（宮城県）、石巻赤十字病院（宮城県）、東北労災病院（宮城県）、仙台医療センター（宮城県）、仙台市立病院（宮城県）、みやぎ県南中核病院（宮城県）、いわき市立総合磐城共立病院（福島県）、岩手県立磐井病院（岩手県）、LCクリニック（宮城県）、坂総合病院（宮城県）、JR仙台病院（宮城県）、仙台赤十字病院（宮城県）、東北医科薬科大学病院（宮城県）、登米市立登米市民病院（宮城県）、大崎市民病院（宮城県）、岩手県立中央病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | 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
Management information
Registered date
| 2018 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036725
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