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Sponsored by: |
Casa Sollievo della Sofferenza IRCCS |
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Information provided by: | Casa Sollievo della Sofferenza IRCCS |
ClinicalTrials.gov Identifier: | NCT00301509 |
To evaluate:
Condition | Intervention | Phase |
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Liver Cirrhosis, Experimental |
Drug: peginterferon and ribavirin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Outcome of Decompensated Hepatitis C Virus-Related Cirrhotic Patients Treated With Peginterferon Alfa-2b and Ribavirin: Results of a Controlled Study |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | December 2005 |
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 |
Genders Eligible for Study: | Both |
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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Italy, Foggia | |
Department of Hepatogastroenterology, CSS | |
San Giovanni Rotondo, Foggia, Italy, 71013 |
Principal Investigator: | Angelo Andriulli, Chief | CSS |
Study ID Numbers: | 630/DS |
Study First Received: | March 10, 2006 |
Last Updated: | March 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00301509 |
Health Authority: | Italy: Ministry of Health |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Fibrosis Ribavirin |
Peginterferon alfa-2b Hepatitis, Viral, Human Liver Cirrhosis Hepatitis C Liver Cirrhosis, Experimental |
Antimetabolites Anti-Infective Agents RNA Virus Infections Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Flaviviridae Infections Therapeutic Uses Antiviral Agents Pharmacologic Actions |