drugset / Trial / NCT00993122
Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The results of antiviral therapy in patients with recurrent hepatitis C after liver transplantation are lower than standard. Ribavirin has immune-modulating effects and seems to be crucial to optimize viral treatment. The aim of this multicenter controlled study is to examine the effect of Ribavirin pre-treatment preceding the combination therapy with peginterferon plus ribavirin on the sustained virological response.
Timeline
- Start
- 2009-10
- Primary completion
- 2010-04
- Completion
- 2012-02
Publications
- Background Gordon FD, Kwo P, Vargas HE. Treatment of hepatitis C in liver transplant recipients. Liver Transpl. 2009 Feb;15(2):126-35. doi: 10.1002/lt.21694.
- Background Furusyo N, Kubo N, Toyoda K, Takeoka H, Nabeshima S, Murata M, Nakamuta M, Hayashi J. Helper T cell cytokine response to ribavirin priming before combined treatment with interferon alpha and ribavirin for patients with chronic hepatitis C. Antiviral Res. 2005 Jul;67(1):46-54. doi: 10.1016/j.antiviral.2005.04.001.
- Background Feld JJ, Nanda S, Huang Y, Chen W, Cam M, Pusek SN, Schweigler LM, Theodore D, Zacks SL, Liang TJ, Fried MW. Hepatic gene expression during treatment with peginterferon and ribavirin: Identifying molecular pathways for treatment response. Hepatology. 2007 Nov;46(5):1548-63. doi: 10.1002/hep.21853.
- Background Ogawa K, Hige S, Nakanishi M, Yamamoto Y, Chuma M, Nagasaka A, Asaka M. Immunological and mutagenic actions of ribavirin monotherapy preceding combination therapy with interferon for patients with chronic hepatitis C. Antivir Ther. 2009;14(4):513-22.
- Background Tox U, Schulte S, Heindl B, Goeser T, Drebber U, Stelzer A, Steffen HM. Ribavirin priming in patients with chronic hepatitis C and normal ALT: a pilot study. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1666-70.
- Background Cuevas JM, Gonzalez-Candelas F, Moya A, Sanjuan R. Effect of ribavirin on the mutation rate and spectrum of hepatitis C virus in vivo. J Virol. 2009 Jun;83(11):5760-4. doi: 10.1128/JVI.00201-09. Epub 2009 Mar 25.
- Background Dixit NM, Perelson AS. The metabolism, pharmacokinetics and mechanisms of antiviral activity of ribavirin against hepatitis C virus. Cell Mol Life Sci. 2006 Apr;63(7-8):832-42. doi: 10.1007/s00018-005-5455-y.
- Background Berenguer M. Systematic review of the treatment of established recurrent hepatitis C with pegylated interferon in combination with ribavirin. J Hepatol. 2008 Aug;49(2):274-87. doi: 10.1016/j.jhep.2008.05.002. Epub 2008 May 22.
- Background Berenguer M, Prieto M, Rayon JM, Mora J, Pastor M, Ortiz V, Carrasco D, San Juan F, Burgueno MD, Mir J, Berenguer J. Natural history of clinically compensated hepatitis C virus-related graft cirrhosis after liver transplantation. Hepatology. 2000 Oct;32(4 Pt 1):852-8. doi: 10.1053/jhep.2000.17924.
- Background Berenguer M, Lopez-Labrador FX, Wright TL. Hepatitis C and liver transplantation. J Hepatol. 2001 Nov;35(5):666-78. doi: 10.1016/s0168-8278(01)00179-9. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | — |
| Comparator | Ribavirin | Small molecule | 10 mg/kg | — |
| Comparator | Ribavirin | Small molecule | 10.4 mg/kg | — |