Chronic Hepatitis C with or without cirrhosis MedDRA version: 6.1 Level: PT Classification code 10019744
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferons
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-
Pharmaceutical Form: Coated table
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed