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Clinical Trial
. 2017 Dec 12:22:740-748.
doi: 10.12659/aot.905898.

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

Ho Joong Choi  1 , Dong Goo Kim  1 , Soon Il Kim  2 , Hee Jung Wang  3 , Jae Won Joh  4 , Kyung Suk Suh  5 , Seong Hoon Kim  6
Affiliations
Clinical Trial

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

Ho Joong Choi et al. Ann Transplant. .

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.

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Figures

Figure 1
Figure 1
Clinical trial participants.
Figure 2
Figure 2
Method of Hepabulin administration: Hepabulin was administered intravenously at a dose of 10,000 IU diluted in 150 mL of 5% dextrose in water according to the following regimen.
Figure 3
Figure 3
Changes in HBV DNA titer after Hepabulin administration in HBV DNA-positive patients (n=13) at 1 week after surgery.
Figure 4
Figure 4
Changes in mean HBsAb titer after administration of Hepabulin.
See this image and copyright information in PMC

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References

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