Improvement of the Surveillance and Control of Liver Disease and Complication Due to Chronic Hepatitis C: Project A) Antiviral Drugs Use, Efficacy, Safety and Costs; Project B) Kinetics of Virological Response.
18 Years
65 Years
Both
Hepatitis C Virus, Chronic Liver Disease, Viral Hepatitis, Therapeutic Uses, Antiviral Agents
Trial Information
Improvement of the Surveillance and Control of Liver Disease and Complication Due to Chronic Hepatitis C: Project A) Antiviral Drugs Use, Efficacy, Safety and Costs; Project B) Kinetics of Virological Response.
(Project B) To evaluate the viral kinetic decay during antiviral combination therapy with
P-IFN alfa-2a and 2b type plus ribavirin.
Inclusion Criteria:
- Naive adult subject
- active HCV infection (HCV-RNA positive)
- histological/biochemical signs of chronic hepatitis or compensated cirrhosis
- willingness of treatment
Exclusion Criteria:
- autoimmune disorders
- severe depression or psychiatric disease
- previous decompensation of cirrhosis
- gastroesophageal bleeding
- hepatocellular carcinoma
- major disease with a life expectancy of less than 5 years
- pregnancy or nursing
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of real dose drugs intake in relation to sustained virological response (SVR).
Outcome Description:
Project A) The analysis will describe the efficacy (SVR) and costs of the 3 different antiviral schedules proposed.
Outcome Time Frame:
Measurement of HCV-RNA at 24° week after therapy withdrawal.
Safety Issue:
No
Principal Investigator
liliana chemello, M.D., Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
University of Padua
Authority:
Italy: Ethics Committee
Study ID:
HEPCOVE protocol
NCT ID:
NCT01195181
Start Date:
September 2005
Completion Date:
August 2010
Related Keywords:
- Hepatitis C Virus
- Chronic Liver Disease
- Viral Hepatitis
- Therapeutic Uses
- Antiviral Agents
- peginterferon alfa 2a and 2b type
- ribavirin
- chronic hepatitis C
- antiviral therapy cost/efficacy
- viral kinetics
- Hepatitis
- Hepatitis A
- Hepatitis, Chronic
- Hepatitis C
- Liver Diseases
- Hepatitis C, Chronic
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