Unique ID issued by UMIN | UMIN000011543 |
---|---|
Receipt number | R000013499 |
Scientific Title | A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT) |
Date of disclosure of the study information | 2013/08/23 |
Last modified on | 2022/07/08 13:37:53 |
A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)
A trial for HBV reactivation in HSCT recipients.
A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)
A trial for HBV reactivation in HSCT recipients.
Japan |
Patients with resolved HBV infection who receive hematopoietic stem cell transplantation
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Malignancy
NO
To determine preventive effect of HB vaccination against reactivation in HSCT recipients with resolved HBV infection (HBsAg(-), HBcAb(+)), we conducted prospective study.
Frequency of HBV reactivation after HSCT and efficacy of HBV-DNA monitoring will be assessed.
Efficacy
Not applicable
Frequency of HBV reactivation in HSCT recipients immunized with HB vaccination.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Vaccine |
HB vaccination
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. Patients who will undergo first HSCT
2. Patients with HBs antigen negative and HBc antibody positive
3. Patients with serum total bilirubin <=2.0mg/dl
4. Patients with serum AST and ALT <= 2.5 x ULN
5. Patients with serum creatinine <= 1.5 xULN
6. Patients with PaO2 >=60Torr on room air or SpO2 >=90%
7.Patients with performance status 0,1 or 2
8. Patients who are 20 to 75 years old
9. Patients who gave consent for this trial
1. Patients with HCV antibody positive
2. Patients with HIV antibody positive
3. Patients who are allergic to vaccination
4. Patients who are allergic to biologics
5. Patients with severe infectious disease (Patients whose general condition seemed to be poor like as septic shock )
6. Patient who undergo hemodialysis
7. Patients with mental disorder which is object of treatment
8. Patients with poorly controlled DM, HT, or heart failure
9. Patients who are pregnant or nursing
10. Patients who are judged ineligible for this trial
66
1st name | Kiminori |
Middle name | |
Last name | Kimura |
Tokyo Metropolitan Komagome Hospital
Division of Hepatology
113-8677
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
03-3823-2101
kiminori_kimura@tmhp.jp
1st name | Kiminori |
Middle name | |
Last name | Kimura |
Tokyo Metropolitan Komagome Hospital
Division of Hepatology
113-8677
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
03-3823-2101
kiminori_kimura@tmhp.jp
Kiminori Kimura
Health labor science research grant
Japanese Governmental office
Japan
Komagome Hospital Institutional Review Board
3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan
0338232101
km_koma_chiken@tmhp.jp
NO
・東京都立駒込病院(東京都)
・東京都立多摩総合医療センター(東京都)
・自治医科大学附属さいたま医療センター(埼玉県)
・東京医科歯科大学(東京都)
・北海道大学医学部(北海道)
・東北大学病院(宮城県)
・国家公務員共済組合連合会 浜の町病院(福岡県)
・兵庫県立がんセンター(兵庫県)
・東海大学医学部(神奈川県)
・久留米大学医学部(福岡県)
・自治医科大学附属病院(栃木県)
2013 | Year | 08 | Month | 23 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 16 | Day |
2013 | Year | 08 | Month | 16 | Day |
2013 | Year | 09 | Month | 01 | Day |
2019 | Year | 01 | Month | 15 | Day |
2013 | Year | 08 | Month | 21 | Day |
2022 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013499