drugset / Trial / NCT01139203
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
RandomizedParallel-groupDouble-blindPrevention
Summary
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.
Timeline
- Start
- 2009-08
- Primary completion
- 2012-12
- Completion
- —
Publications
- Background Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.
- Background Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.
- Background Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.
- Background Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adefovir | Unknown | 10 mg | Oral |
| Comparator | Entecavir | Small molecule | 0.5 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 100 mg | Oral |
| Comparator | hepatitis B immune globulin | Protein / enzyme biologic | 400 iu | Intravenous |