drugset / Trial / NCT00135798
Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation
Phase 2
Completed
79 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ortho Biotech Clinical Affairs, L.L.C. · collabSchering-Plough · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver transplant.
Timeline
- Start
- 2005-09
- Primary completion
- 2009-12
- Completion
- 2009-12
Outcome
Met primary endpoint
registry Standard Care Group: Genotypes 1, 4, 6 vs LADR Treatment Group: Genotypes 1, 4, 6 vs LADR Treatment Group: Genotypes 2, 3; p = 0.0477 NCT00135798 ↗
registry Standard Care Group: Genotypes 1, 4, 6 vs LADR Treatment Group: Genotypes 1, 4, 6 vs LADR Treatment Group: Genotypes 2, 3; p = 0.0274 NCT00135798 ↗
Publications
- Background Everson GT, Trotter J, Forman L, Kugelmas M, Halprin A, Fey B, Ray C. Treatment of advanced hepatitis C with a low accelerating dosage regimen of antiviral therapy. Hepatology. 2005 Aug;42(2):255-62. doi: 10.1002/hep.20793.
- Background Stravitz RT, Shiffman ML, Sanyal AJ, Luketic VA, Sterling RK, Heuman DM, Ashworth A, Mills AS, Contos M, Cotterell AH, Maluf D, Posner MP, Fisher RA. Effects of interferon treatment on liver histology and allograft rejection in patients with recurrent hepatitis C following liver transplantation. Liver Transpl. 2004 Jul;10(7):850-8. doi: 10.1002/lt.20189.
- Background Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047.
- Background Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.
- Results Everson GT, Terrault NA, Lok AS, Rodrigo del R, Brown RS Jr, Saab S, Shiffman ML, Al-Osaimi AM, Kulik LM, Gillespie BW, Everhart JE; Adult-to-Adult Living Donor Liver Transplantation Cohort Study. A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation. Hepatology. 2013 May;57(5):1752-62. doi: 10.1002/hep.25976. Epub 2013 Jan 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | — |
| Subject | Ribavirin | Small molecule | 1000 mg | — |
| Subject | Ribavirin | Small molecule | 1200 mg | — |