Hepatitis C | Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients
Hepatitis C research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Liver transplantation from > 6 months 2. Positive HCV-RNA viremia 3. Elevated transaminase levels (greater than 1,2 normal values) in at least two consecutive determinations during the last month 4. Histology pattern showing hepatitis C recurrence Exclusion Criteria: 1. Multiple organ transplantation 2. Histology showing evidence of hepatic allograft rejection > 3/9 RAI score 3. Concomitant active biliary disease 4. Concomitant HBV infection 5. Normal transaminases levels 6. Less than 1500 neutrophiles in more than one blood test 7. Less than 50000 platelets in more than one blood test 8. Hemoglobin < 9 g/ dL 9. Creatinine clearance < 35 ml/min 10. Positive antibodies > 1:80 11. Auto-immune thyroid pathology 12. Severe psychiatric disease 13. Diagnosis of ischemic cardiopathy in the last 12 months 14. Active alcohol abuse 15. Low compliance to other medical treatments
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ribavirin pre-treatmentpatients receive ribavirin (10,4 mg/kg/day) and pegylated interferon alfa-2b (1,5 mcg/kg/week).Pre-treatment arm will receive a 8-week monotherapy treatment with only ribavirin (same dosage) and the controlled arm will receive 48 week of standard combined therapy (ribavirin plus pegylated interferon)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ribavirin pre-treatmentpatient will receive ribavirin in monotherapy for 8 weeks before the combined 48 weeks antiviral therapy
combined stardard therapypatients will receive the standard combined therapy with ribavirin and pegylated interferon for 48 weeks
Start Date: October 2009
Completed Date: February 2012
Phase: Phase 4
Primary Outcome: HCV-RNA level, Transaminases level
Secondary Outcome: liver biopsy and Transient elastography at baseline and after six month since therapy conclusion
Study sponsors, principal investigator, and references
Lead Sponsor: University of Roma La Sapienza
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. Review.