Tailoring antiviral therapy of chronic hepatitis C to the single patient standard therapy versus treatment guided by a physic-mathematical model of the dynamics of Hepatitis C Virus infection. - Tailoring antiviral therapy by HCV dynamics

Conditions: Chronic Hepatitis C with or without cirrhosis
MedDRA version: 6.1Level: PTClassification code 10019744

Registration Number: EUCTR2006-002483-26-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Patients with chronic hepatitis C with or without cirrhosis and are either therapy na ve or were relapsers after a previous standard therapy course. Their age will range between 18 and 70 years and females have to be willing to be able to take preventive contraceptive measures during treatment and for 6 months after the end of therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or breast feeding women; Chronic liver disease with signs of portal hypertension oesophageal or gastric varices at endoscopy and or history of episodes of liver decompensation; Hepatocellular carcinoma; Subjects with organ transplant, except corneal and hair transplants; Known or suspected toxicity from standard Interferons, PEG-Interferons or ribavirin; Treatment with any other experimental drugs within 30 days since the recruitment date; Subjects with any form of haemoglobin disease, not only major and minor talaxemia; Positive HIV sierology

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: a. To evaluate and compare the overall costs and the pharmaco-economical aspects of drug efficacy in the two different therapy strategies standard treatment according to the guidelines of the Italian Association for the Study of the Liver 4 and treatment tailored to the single patient by using the simulations of the HCV infected hepatocytes provided by the mathematical model of HCV dynamics. b. To evaluate and compare the mean therapy durations in weeks needed to achieve a sustained response by the two different therapeutic strategies.;Secondary Objective: To analyse the impact of the two different therapeutic strategies in terms of Sustained Virological Response;Primary end point(s): Number of weeks of therapy required for one sustained virological response

Secondary Outcome Measures