Unique ID issued by UMIN | UMIN000021793 |
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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 |
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Japan |
chronic hepatitis B
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
NO
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
Safety,Efficacy
Decrease in serum HBsAg level on week 240
Proportion of viral breakthrough until week 240
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Group 1: Continue entecavir
Group 2: Switch to tenofovir
Not applicable |
Not applicable |
Male and Female
1. treated with Entecavir for 5 years or longer
2. HBV-DNA<2.1 log copies/mL
3. HBsAg-positive
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
90
1st name | Masaru |
Middle name | |
Last name | Enomoto |
Osaka Metropolitan University
Department of Hepatology
545-8585
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3905
enomoto-m@med.osaka-cu.ac.jp
1st name | Masaru |
Middle name | |
Last name | Enomoto |
Osaka Metropolitan University
Department of Hepatology
545-8585
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3905
enomoto-m@med.osaka-cu.ac.jp
Department of Hepatology, Osaka Metropolitan University
None
Self funding
Osaka Metropolitan University IRB
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
06-6645-2711
ishomu@med.osaka-cu.ac.jp
NO
2020 | Year | 12 | Month | 31 | Day |
Unpublished
Open public recruiting
2015 | Year | 07 | Month | 15 | Day |
2015 | Year | 07 | Month | 15 | Day |
2015 | Year | 07 | Month | 15 | Day |
2023 | Year | 12 | Month | 31 | Day |
2016 | Year | 04 | Month | 06 | Day |
2023 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021278
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