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Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301509
First Posted: March 13, 2006
Last Update Posted: March 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Casa Sollievo della Sofferenza IRCCS
  Purpose

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: None (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.
  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301509


Locations
Italy
Department of Hepatogastroenterology, CSS
San Giovanni Rotondo, Foggia, Italy, 71013
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Investigators
Principal Investigator: Angelo Andriulli, Chief CSS
  More Information

ClinicalTrials.gov Identifier: NCT00301509     History of Changes
Other Study ID Numbers: 630/DS
First Submitted: March 10, 2006
First Posted: March 13, 2006
Last Update Posted: March 13, 2006
Last Verified: December 2005

Additional relevant MeSH terms:
Hepatitis C
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Experimental
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents