Unique ID issued by UMIN | UMIN000006943 |
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Receipt number | R000008122 |
Scientific Title | Efficacy and safety of Entecavir/PEG-IFN-alpha sequential therapy for chronic active hepatitis B |
Date of disclosure of the study information | 2015/03/31 |
Last modified on | 2023/07/03 13:34:51 |
Efficacy and safety of Entecavir/PEG-IFN-alpha sequential therapy for chronic active hepatitis B
Entecavir/PEG-IFN-alpha sequential therapy for chronic hepatitis B (B-SHOOT study)
Efficacy and safety of Entecavir/PEG-IFN-alpha sequential therapy for chronic active hepatitis B
Entecavir/PEG-IFN-alpha sequential therapy for chronic hepatitis B (B-SHOOT study)
Japan |
chronic active hepatitis B
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
NO
To assess the efficacy and safety of entecavir/PEG-IFN-alpha sequential therapy for patients with chronic active hepatitis B
Safety,Efficacy
negative HBeAg, undetectable HBV DNA, and normal ALT at 6 months after the end of treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
PEG-IFN-alpha 180mcg given by subcutaneous injection once a week for 48 weeks. In the first 4 weeks, Entecavir 0.5mg also given orally once daily.
Not applicable |
Not applicable |
Male and Female
Patients with chronic active hepatitis B who have been treated with Entecavir for 36-72 weeks
1. presence of resistance to nucleoside analog (such as lamivudine and entecavir)
2. decompensated liver disease (total bilirubin >=2.0 mg/dL, prothrombin time <70 %, and albumin <3.6 g/dL)
3. other likely causes of chronic liver disease, such as autoimmune or alcoholic liver disease
4. severe complication (ex. impaired renal, cardiac or respiratory function)
5. women who are possibly pregnant, expectant mothers, and lactating mothers
6. history of interstitial pneumonitis
7. drug allegy to interferon
8. depression or other severe psychosomatic disorders
9. Unacceptable values of complete blood counts as follows:
i) WBC counts=<3,000/microL
ii) Neutrophil counts=<1,500/microL
iii) Hemoglobin concentration=<12g/dL
iv) Platelet counts=<90,000/microL
50
1st name | Masaru |
Middle name | |
Last name | Enomoto |
Osaka City University Graduate School of Medicine
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 City University Graduate School of Medicine
Department of Hepatology
545-8585
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3811
enomoto-m@med.osaka-cu.ac.jp
Department of Hepatology, Osaka City University Graduate School of Medicine
None
Self funding
Ethical Committee of Osaka City University Graduate School of Medicine
1-2-7 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3457
ethics@med.osaka-cu.ac.jp
NO
2015 | Year | 03 | Month | 31 | Day |
Unpublished
Open public recruiting
2011 | Year | 12 | Month | 06 | Day |
2011 | Year | 12 | Month | 06 | Day |
2012 | Year | 01 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2011 | Year | 12 | Month | 24 | Day |
2023 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008122
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