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Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis

This study has been completed.
Information provided by:
Casa Sollievo della Sofferenza IRCCS Identifier:
First received: March 10, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted

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.

Condition Intervention Phase
Liver Cirrhosis, Experimental Drug: peginterferon and ribavirin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Outcome of Decompensated Hepatitis C Virus-Related Cirrhotic Patients Treated With Peginterferon Alfa-2b and Ribavirin: Results of a Controlled Study

Resource links provided by NLM:

Further study details as provided by Casa Sollievo della Sofferenza IRCCS:

Study Start Date: January 2002
Estimated Study Completion Date: December 2005
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 model of the natural history of chronic hepatitis C and projected the total number of cases with cirrhosis increased by more than 50% by 2010 and then plateaued (3). As a result, there will be a dramatic increase in the number of cases with complications of liver failure and decompensated events of cirrhosis will increase to 25% in 2010, 32% in 2020, 36% in 2030, and 38% in 2040 (3, table 1).Liver transplantation is the treatment of choice but the limited number of organ donor makes not realizable for the major of patients. Furthermore, age over 65 years correlated disease is not accepted to enter into the list of liver transplant. To prevent these patients from worsening their liver disease has positive economic implications in terms of health care resources used as diagnostic tests, clinic visits, drug therapy, hospitalization for management of complications, and later on, liver transplantation, and indirect costs related to lost work time and impaired quality of life. our controlled study on antiviral treatment of decompensated cirrhotics has shown that HCV clearance by therapy can be life-saving, improves hepatic function, and reduces disease progression. Treatment should be encouraged in CTP classes A and B, and especially in patients infected by genotype 2. The benefit of treating patients with genotype 1 remains unproven.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its identifier: NCT00301509

Department of Hepatogastroenterology, CSS
San Giovanni Rotondo, Foggia, Italy, 71013
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Principal Investigator: Angelo Andriulli, Chief CSS
  More Information Identifier: NCT00301509     History of Changes
Other Study ID Numbers: 630/DS
Study First Received: March 10, 2006
Last Updated: March 10, 2006

Additional relevant MeSH terms:
Hepatitis C
Liver Cirrhosis
Liver Cirrhosis, Experimental
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Pathologic Processes
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents processed this record on August 16, 2017