Cited 5 times in
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
DC Field | Value | Language |
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dc.contributor.author | 김순일 | - |
dc.date.accessioned | 2023-08-09T02:32:27Z | - |
dc.date.available | 2023-08-09T02:32:27Z | - |
dc.date.issued | 2017-12 | - |
dc.identifier.issn | 1425-9524 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195619 | - |
dc.description.abstract | 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | International Scientific Literature, Inc. | - |
dc.relation.isPartOf | ANNALS OF TRANSPLANTATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Hepatitis B / drug therapy | - |
dc.subject.MESH | Hepatitis B / surgery | - |
dc.subject.MESH | Hepatitis B / therapy* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunoglobulins / therapeutic use* | - |
dc.subject.MESH | Liver Transplantation* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Secondary Prevention | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학교실) | - |
dc.contributor.googleauthor | Ho Joong Choi | - |
dc.contributor.googleauthor | Dong Goo Kim | - |
dc.contributor.googleauthor | Soon Il Kim | - |
dc.contributor.googleauthor | Hee Jung Wang | - |
dc.contributor.googleauthor | Jae Won Joh | - |
dc.contributor.googleauthor | Kyung Suk Suh | - |
dc.contributor.googleauthor | Seong Hoon Kim | - |
dc.identifier.doi | 10.12659/aot.905898 | - |
dc.contributor.localId | A00649 | - |
dc.relation.journalcode | J00184 | - |
dc.identifier.eissn | 2329-0358 | - |
dc.identifier.pmid | 29229898 | - |
dc.contributor.alternativeName | Kim, Soon Il | - |
dc.contributor.affiliatedAuthor | 김순일 | - |
dc.citation.volume | 22 | - |
dc.citation.startPage | 740 | - |
dc.citation.endPage | 748 | - |
dc.identifier.bibliographicCitation | ANNALS OF TRANSPLANTATION, Vol.22 : 740-748, 2017-12 | - |
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