PMID- 29229898
OWN - NLM
STAT- MEDLINE
DCOM- 20181010
LR  - 20220408
IS  - 2329-0358 (Electronic)
IS  - 1425-9524 (Print)
IS  - 1425-9524 (Linking)
VI  - 22
DP  - 2017 Dec 12
TI  - A Multicenter Phase III Study to Evaluate the Efficacy and Safety of Hepabulin, a 
      New Hepatitis B Immunoglobulin, in Liver Transplantation Recipients with 
      Hepatitis B.
PG  - 740-748
AB  - BACKGROUND This study was performed to evaluate the effects and stability of the 
      new hepatitis B immunoglobulin (HBIG), Hepabulin, in patients undergoing liver 
      transplantation for hepatitis B. MATERIAL AND METHODS A total of 87 patients 
      undergoing liver transplantation for hepatitis B-related liver disease were 
      enrolled in this multicenter, phase III, open-label, single-arm study. Seventy 
      (80.5%) of the 87 enrolled patients completed the study during the 52-week study 
      period. Hepabulin (10,000 units) was intravenously injected intraoperatively, 
      daily for 1 week, weekly for 1 month, and then once per month. Hepabulin was used 
      as monotherapy without antiviral agents. Hepatitis B recurrence was defined as 
      conversion from negativity for surface antigen after HBIG administration to 
      positivity. RESULTS There were no cases of hepatitis B recurrence during the 
      52-week observation period. A total of 876 adverse events (AEs) that occurred 
      during the study period were observed in 83 (95.4%) of 87 patients, and serious 
      AEs were seen in 119 cases in 44 (50.6%) of the 87 patients. None of the AEs 
      showed a relationship with this drug. Hepatitis B surface antigen (HBsAg) and 
      hepatitis B e antigen (HBeAg) rapidly disappeared within 1 week after HBIG 
      administration, but hepatitis B virus (HBV) DNA persisted for up to 8 weeks after 
      surgery, which was related to HBV viral load. Hepatitis B surface antibody 
      (HBsAb) was correlated with HBIG (Hepabulin) dose. CONCLUSIONS The new HBIG, 
      Hepabulin, was shown to be safe and effective in preventing the recurrence of HBV 
      after liver transplantation.
FAU - Choi, Ho Joong
AU  - Choi HJ
AD  - Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, South Korea.
FAU - Kim, Dong Goo
AU  - Kim DG
AD  - Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, South Korea.
FAU - Kim, Soon Il
AU  - Kim SI
AD  - Department of Transplantation Surgery, Severance Hospital, Yonsei University 
      College of Medicine, Seoul, South Korea.
FAU - Wang, Hee Jung
AU  - Wang HJ
AD  - Department of Surgery, Ajou University School of Medicine, Suwon, South Korea.
FAU - Joh, Jae Won
AU  - Joh JW
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, South Korea.
FAU - Suh, Kyung Suk
AU  - Suh KS
AD  - Department of Surgery, College of Medicine, Seoul National University, Seoul, 
      South Korea.
FAU - Kim, Seong Hoon
AU  - Kim SH
AD  - Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, 
      Goyang, South Korea.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171212
PL  - United States
TA  - Ann Transplant
JT  - Annals of transplantation
JID - 9802544
RN  - 0 (Immunoglobulins)
RN  - XII270YC6M (hepatitis B hyperimmune globulin)
SB  - IM
MH  - Female
MH  - Hepatitis B/drug therapy/surgery/*therapy
MH  - Humans
MH  - Immunoglobulins/*therapeutic use
MH  - *Liver Transplantation
MH  - Male
MH  - Middle Aged
MH  - Secondary Prevention
MH  - Treatment Outcome
PMC - PMC6248297
EDAT- 2017/12/13 06:00
MHDA- 2018/10/12 06:00
PMCR- 2017/12/12
CRDT- 2017/12/13 06:00
PHST- 2017/12/13 06:00 [entrez]
PHST- 2017/12/13 06:00 [pubmed]
PHST- 2018/10/12 06:00 [medline]
PHST- 2017/12/12 00:00 [pmc-release]
AID - 905898 [pii]
AID - 10.12659/aot.905898 [doi]
PST - epublish
SO  - Ann Transplant. 2017 Dec 12;22:740-748. doi: 10.12659/aot.905898.