randomized study for hcv recurrence treatment in liver transplant patients with ribavirin pre-treatment for 8 weeks follwed by stadard therapy (48 weeks) with interferon pegylated and ribavirin vs standard antivirla therapy with pegylated interferon and ribavirin ofr 48 weeks. - PEAR
- Conditions
- liver tranplanted patients with diagnosis of Hepatitis C recurrenceMedDRA version: 9.1Level: SOCClassification code 10019805
- Registration Number
- EUCTR2010-018870-19-IT
- Lead Sponsor
- AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
HCV-RNA positive
High level of transaminases
Liver biopsy in keeping wih hcv recurrence
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
liver reject
disease of biliary tract
hbv infection
cytopenia
anemia
autoantibodies
kidney trnaplant
depression
denied agreement consense
alcol abuse
ischemic cardiopathy
age>70 years
no compliance to treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the efficacy of pre-treatment with ribavirin (8 weeks) followed by pegylated interferon and ribavirin in patient with HCV recurrence after liver transplant;Secondary Objective: compliance to therapy. biochemical response (ALT level). plasma concentration of ribavirin and effects on lymphocitic response;Primary end point(s): susteined virological response six months later the conclusion of therapy
- Secondary Outcome Measures
Name Time Method