Last updated: 11/07/2018 17:54:00
A multicenter, prospective, descriptive study to compare the efficacy of lamivudine alone versus lamivudine plus anti-HB hyperimmune gammaglobulin in the prevention of hepatitis B virus reinfection after liver transplant.
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A multicenter, prospective, descriptive study to compare the efficacy of lamivudine alone versus lamivudine plus anti-HB hyperimmune gammaglobulin in the prevention of hepatitis B virus reinfection after liver transplant.
Trial description: A multicenter, prospective, descriptive study to compare the efficacy of lamivudine alone versus lamivudine plus anti-HB hyperimmune gammaglobulin in the prevention of hepatitis B virus reinfection after liver transplant.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Buti M, Mas A, Prieto M, Casafont F, Gonzalez A, Miras M, Herrero JI, Jardi R, Cruz de Castro E, Garcia-Rey C. A randomized study comparing lamivudine monotherapy after a short course of hepatitis B immune globulin (HBIG) and lamivudine with long-term lamivudine plus HBIG in the prevention of hepatitis B virus recurrence after liver transplantation. J Hepatol. 2003 Jun;38(6):811-7.
Combination prophylaxis with hepatitis B immunoglobulin and lamivudine after liver transplantation minimizes hbv recurrence rates unless evolution of pretransplant lamivudine resistance. Seehofer, D., Rayes, N., Steinmuller, T., Muller, A. R., Jonas, S., Settmacher, U., Neuhaus, R., Berg, T., and Neuhaus, P. Z Gastroenterol 2002; 40(9):795-9
Combined lamivudine and hepatitis B immunoglobulin for the prevention of hepatitis B recurrence after liver transplantation: long-term results. Dumortier, J., Chevallier, P., Scoazec, J. Y., Berger, F., and Boillot, O. Am J Transplant 2003; 3(8):999-1002
Evolving experience of hepatitis B virus prophylaxis in liver transplantation. Honaker, M. R., Shokouh-Amiri, M. H., Vera, S. R., Alloway, R. R., Grewal, H. P., Hardinger, K. L., Kizilisik, A. T., Bagous, T., Trofe, J., Stratta, R. J., Egidi, M. F., and Gaber, A. O. Transpl Infect Dis 2002; 4(3):137-43
Lamivudine after hepatitis B immune globulin is effective in preventing hepatitis b recurrence after liver transplantation. Dodson, S. F., de Vera, M. E., Bonham, C. A., Geller, D. A., Rakela, J., and Fung, J. J. Liver Transpl 2000; 6(4):434-9
Management of hepatitis b in liver transplantation patients. Samuel, D. Semin Liver Dis 2004; 24 Suppl 1(55-62)
mpact of anti-hepatitis bc-positive grafts on the outcome of liver transplantation for hbv-related cirrhosis. Joya-Vazquez, P. P., Dodson, F. S., Dvorchik, I., Gray, E., Chesky, A., Demetris, A. J., Shakil, O., Fung, J. J., and Vargas, H. E. Transplantation 2002; 73(10):1598-602
Medical condition
Hepatitis B
Product
lamivudine
Collaborators
Not applicable
Study date(s)
March 1998 to September 2002
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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