Unique ID issued by UMIN | UMIN000001756 |
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Receipt number | R000002080 |
Scientific Title | Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation |
Date of disclosure of the study information | 2009/03/05 |
Last modified on | 2013/04/02 13:13:23 |
Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation
HBIG plus LAM to prevent HBV recurrence
Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation
HBIG plus LAM to prevent HBV recurrence
Japan |
Liver transplant candidates with end-stage liver diseases due to hepatitis B.
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Others
NO
To evaluate safety and efficacy of HBIG plus LAM therapy among Japanese liver transplant recipients.
Safety,Efficacy
Exploratory
Not applicable
The rate of hepatitis B recurrence post liver-transplantation.
To compare the rate of Hepatitis B recurrence post liver-transplantation to our histolical control (HBIG alone).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Lamivudine
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients undergoing/underwent liver transplantation for hepatitis B-related end-stage liver diseases.
2)Patients who comply with periodical intra-vascular administration of HBIG.
3)HBV-DNA undetectable at 3 weeks post liver transplantation.
4)HBsAg negative at 3 weeks post liver transplantation.
5)GOT <= 2X UNL (upper normal limit) and GPT <= 2X UNL.
1) HIV co-infection.
2) Lamivudine sensitivity.
3) Severe renal dysfunction (serum Cr >= 2.0 mg/dL)
4) Resistance to Lamivudine.
20
1st name | |
Middle name | |
Last name | Yasuhiko Sugawara |
University of Tokyo
The Artificial Organ and Transplantation Division, Department of Surgery
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
03-3815-5411
1st name | |
Middle name | |
Last name | Noriyo Yamashiki |
University of Tokyo
Organ Transplantation Service
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
03-3815-5411
nyamashiki-gi@umin.ac.jp
Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, University of Tokyo
None
Self funding
Japan
NO
2009 | Year | 03 | Month | 05 | Day |
Unpublished
Target sample size was not achieved.
Terminated
2009 | Year | 01 | Month | 22 | Day |
2009 | Year | 02 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2009 | Year | 03 | Month | 04 | Day |
2013 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002080
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