Status:
COMPLETED
Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
Lead Sponsor:
Azienda Ospedaliera di Padova
Collaborating Sponsors:
Regione Veneto
University of Padova
Conditions:
Hepatitis C Virus
Chronic Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the world, being the major cause of progressive liver disease, primary hepatic cancer and liver transplantation. Toda...
Detailed Description
(Project B) To evaluate the viral kinetic decay during antiviral combination therapy with P-IFN alfa-2a and 2b type plus ribavirin.
Eligibility Criteria
Inclusion
- Naive adult subject
- active HCV infection (HCV-RNA positive)
- histological/biochemical signs of chronic hepatitis or compensated cirrhosis
- willingness of treatment
Exclusion
- autoimmune disorders
- severe depression or psychiatric disease
- previous decompensation of cirrhosis
- gastroesophageal bleeding
- hepatocellular carcinoma
- major disease with a life expectancy of less than 5 years
- pregnancy or nursing
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT01195181
Start Date
September 1 2005
End Date
August 1 2010
Last Update
September 6 2010
Active Locations (1)
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1
Department of Clinical and Experimental Medicine, Out-patients Hepatologic Unit, Azienda Ospedaliera di Padova.
Padua, Italy, 35100