Status:
COMPLETED
Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Hepatitis C
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE4
Brief 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...
Detailed Description
Ribavirin Pre-Treatment Study Protocol 1. Introduction: * Recurrence of hepatitis C infection and liver transplant: Recurrence of hepatitis C after liver transplant is almost universal. After...
Eligibility Criteria
Inclusion
- Liver transplantation from \> 6 months
- Positive HCV-RNA viremia
- Elevated transaminase levels (greater than 1,2 normal values) in at least two consecutive determinations during the last month
- Histology pattern showing hepatitis C recurrence
Exclusion
- Multiple organ transplantation
- Histology showing evidence of hepatic allograft rejection \> 3/9 RAI score
- Concomitant active biliary disease
- Concomitant HBV infection
- Normal transaminases levels
- Less than 1500 neutrophiles in more than one blood test
- Less than 50000 platelets in more than one blood test
- Hemoglobin \< 9 g/ dL
- Creatinine clearance \< 35 ml/min
- Positive antibodies \> 1:80
- Auto-immune thyroid pathology
- Severe psychiatric disease
- Diagnosis of ischemic cardiopathy in the last 12 months
- Active alcohol abuse
- Low compliance to other medical treatments
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00993122
Start Date
October 1 2009
End Date
February 1 2012
Last Update
June 22 2015
Active Locations (1)
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1
Sapienza University of Rome
Rome, Rome, Italy, 00100