Hepatitis C Clinical Trial
The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.
The aim of the study is to assess whether patients fulfilling the criteria as defined in
section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This
study will be open to all patients with histologically documented hepatitis C recurring
after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and
irrespectively of the pattern of response to a previous antiviral treatment (if any).
The benefit will be assessed in terms of biochemical (normalization of serum transaminases
levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of
the histological signs of hepatitis) response. The presence of a sustained virological
response, as defined below in section 6, will also be studied in relation to the early
kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C
patients, which suggest that an early rapid decrease of HCV viremia is associated with a
durable response.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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