Overview

Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis

Status:
Completed

Trial end date:
2005-12-01

Target enrollment:
0

Participant gender:
All

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. A controlled study. 2. safety and efficacy of antiviral therapy in this population by using a statistically significally number of patients as controls.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Casa Sollievo della Sofferenza IRCCS

Treatments:

Peginterferon alfa-2b
Ribavirin

Criteria

Inclusion Criteria: HCV cirrhotics admitted to hospital for a decompensated event, such as
ascites, variceal bleeding, and hepatic encephalopathy -

Exclusion Criteria: 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.

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