Status:
COMPLETED
Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis
Lead Sponsor:
Casa Sollievo della Sofferenza IRCCS
Conditions:
Liver Cirrhosis, Experimental
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate: 1. the impact of combined antiviral therapy (Peginterferon plus ribavirin) on natural history of patients affected with HCV decompensated cirrhosis, after sustained virological response....
Detailed Description
Decompensated HCV cirrhosis is a relevant problem as its clinical evidences predisposes to an high mortality risk, with a survival rate of 50% at 5 years (1,2). Davis et. al processed a mathematical m...
Eligibility Criteria
Inclusion
- HCV cirrhotics admitted to hospital for a decompensated event, such as ascites, variceal bleeding, and hepatic encephalopathy -
Exclusion
- rapid deterioration of liver and/or renal function, detection of hepatocarcinoma, infection with HIV or HBV viruses, current alcohol or drug abuse, chronic invalidating disease, bacterial infections, platelets \<35,000 cells/μL, neutrophils \<1,000 cells/μL, haemoglobin level \<10 g/dL, total bilirubin \>3 mg/dL, and serum creatinine \>2.0 mg/dL.
- \-
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00301509
Start Date
January 1 2002
End Date
December 1 2005
Last Update
March 13 2006
Active Locations (1)
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1
Department of Hepatogastroenterology, CSS
San Giovanni Rotondo, Foggia, Italy, 71013