UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021793
Receipt number R000021278
Scientific Title Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Date of disclosure of the study information 2020/12/31
Last modified on 2023/04/12 09:50:30

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Basic information

Public title

Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial

Acronym

Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial

Scientific Title

Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial

Scientific Title:Acronym

Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial

Region

Japan


Condition

Condition

chronic hepatitis B

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in patients with chronic hepatitis B who underwent entecavir treatment for a long term

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Decrease in serum HBsAg level on week 240

Key secondary outcomes

Proportion of viral breakthrough until week 240


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

Group 1: Continue entecavir

Interventions/Control_2

Group 2: Switch to tenofovir

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. treated with Entecavir for 5 years or longer
2. HBV-DNA<2.1 log copies/mL
3. HBsAg-positive

Key exclusion criteria

1. no previous use of other nucleoside analog
2. presence of resistance to nucleoside analog
3. other likely causes of chronic liver disease, such as autoimmune or alcoholic liver disease
4. viable HCC or other malignancies
5. decompensated liver function (Child B or C)
6. severe complication (ex. impaired renal, cardiac or respiratory function)
7. women who are possibly pregnant, expectant mothers, and lactating mothers
8. history of allergy to nucleoside analog

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Masaru
Middle name
Last name Enomoto

Organization

Osaka Metropolitan University

Division name

Department of Hepatology

Zip code

545-8585

Address

1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3905

Email

enomoto-m@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Masaru
Middle name
Last name Enomoto

Organization

Osaka Metropolitan University

Division name

Department of Hepatology

Zip code

545-8585

Address

1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3905

Homepage URL


Email

enomoto-m@med.osaka-cu.ac.jp


Sponsor or person

Institute

Department of Hepatology, Osaka Metropolitan University

Institute

Department

Personal name



Funding Source

Organization

None

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

Osaka Metropolitan University IRB

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8585, Japan

Tel

06-6645-2711

Email

ishomu@med.osaka-cu.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

2020 Year 12 Month 31 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

Open public recruiting

Date of protocol fixation

2015 Year 07 Month 15 Day

Date of IRB

2015 Year 07 Month 15 Day

Anticipated trial start date

2015 Year 07 Month 15 Day

Last follow-up date

2023 Year 12 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

2016 Year 04 Month 06 Day

Last modified on

2023 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name