Unique ID issued by UMIN | UMIN000001627 |
---|---|
Receipt number | R000001934 |
Scientific Title | Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial |
Date of disclosure of the study information | 2013/03/31 |
Last modified on | 2014/11/06 09:18:55 |
Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial
Entecavir plus HB vaccine combination trial
Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial
Entecavir plus HB vaccine combination trial
Japan |
HBeAg-positive chronic hepatitis B
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
NO
To assess the safety and efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration
Safety,Efficacy
negative HBeAg, undetectable HBV DNA, and normal ALT at month 12 of entecavir plus HB vaccine combination therapy
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine | Vaccine |
Continue oral entecavir administration at a daily dose of 0.5 mg for 12 months
Add HB vaccine (to entecavir) by intramuscular injection at a monthly dose of 10 microg for 12 months
20 | years-old | <= |
80 | years-old | > |
Male and Female
1.persistent or fluctuating elevations of serum ALT for at least 6 months before the start of entecavir
2.positive HBeAg before the start of entecavir
3.detectable HBV DNA before the start of entecavir
4.still HBeAg-positive after one year of entecavir administration
1.use of lamivudine or any other nucleos(t)ide analogues for hepatitis B
2.use of immunosuppressive or immunomodulatory drugs
3.presence of HCV infection and other likely causes of chronic liver disease
4.clinical signs of decompensated cirrhosis or liver failure
5.severe complication (poor renal, cardiac, or respiratory function)
6.women who are possibly pregnant, expectant mothers, and lactating mothers
50
1st name | |
Middle name | |
Last name | Akihiro Tamori |
Osaka City University Graduate School of Medicine
Department of Hepatology
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
06-6645-3811
atamori@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Akihiro Tamori |
Osaka City University Graduate School of Medicine
Department of Hepatology
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
06-6645-3435
atamori@med.osaka-cu.ac.jp
Osaka City University Graduate School of Medicine
None
Self funding
NO
2013 | Year | 03 | Month | 31 | Day |
Unpublished
The present study showed that HB vaccine therapy did not have anti-HBV effect for patients with entecavir poor response.
Completed
2008 | Year | 04 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 08 | Month | 31 | Day |
2014 | Year | 09 | Month | 30 | Day |
2009 | Year | 01 | Month | 07 | Day |
2014 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001934