Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Interferons; Ribavirin

Criteria

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