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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032201
Receipt No. 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 2018/04/11

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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
Email 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
Email m-nino5@hello.odn.ne.jp

Sponsor
Institute Department of Gastroenterology, Tohoku University Hospital
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
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
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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