Chronic infection with hepatitis C virus, genotype 1, with signs of liver inflammation.
Conditions
Interventions
Trade Name: Pegasys
Product Name: Pegasys
Product Code: Ro25-8310/V01
Pharmaceutical Form: Solution for injection
Trade Name: Copegus
Product Name: Copegus
Product Code: R20-9963/J10
Pharmaceutical
Sponsors
Västra Götalandsregionen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females =18 years of age Anti-HCV positiva for a longer duration than 6 months HCV-RNA >1000 IU/mL Genotype 1 of HCV ALT >1 x upper limit of normal Compensated liver disease Negative pregnancy test for fertile females 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or breast feeding Antiviral, cytostatic or immunomodulating therapy 6 months before start of treatment Hepatitis B or HIV infektion (HBsAg, anti-HIV) Hemochromatosis, autoimmune hepatitis, alkohol liver disease Previous bleeding esophagusvarices of other signs of decompensated liver disease Neutrophile leucocytes 1.5 x upper limit of normal History of severe mental disorder, in particular severe depression History of epilepsy Autoimmune disease, severe heart disease, organ transplantation, malignancy, thyreoidea disease, severe retinopathy Current or recent drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the cost-efficacy and sustained virological response rate for an individualized treatment duration of hepatitis C genotype 1 using a combvination of Pegasys and Copegus;Secondary Objective: To study the relation between viral kinetics and sustained virological response. To analyse the association between the sustained virological response and baseline parameters (including HCV-RNA and IP-10). To study the importance of dose reductions for the therapeutic outcome, in particular for patients with borderline responses.;Primary end point(s): Required treatment weeks per cured and non-cured patient Sustained virological response | — |
Countries
Sweden
Outcome results
None listed