chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA < 50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.
Conditions
Interventions
Trade Name: Pegasys
Product Name: Pegasys
Product Code: Ro25-8310/V01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: peginterferon alfa-2a
CAS Number: 198153-51-4
Concentration unit
Sponsors
Sahlgrenska University Hospital, Östra
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients = 18 years of age • Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test • Serum HCV-RNA = 15 IU/mL. • HCV genotype 2 or 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period. • Previous relapse (i.e. HCV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Women with ongoing pregnancy or breast feeding • Previous non-response during treatment (as defined as having detectable HCV RNA = 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks. • Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study. • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) = 6 months prior to the first dose of study drug • Any investigational drug = 6 weeks prior to the first dose of study drug. • HCV genotype 1, 4, 5 or 6 infection. • Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab • Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) • History or other evidence of decompensated liver disease • Neutrophil count 2 mg/dl (> 124 µmol/L) or creatinine clearance < 50 ml/minute at screening • Severe psychiatric disease, especially depression, as judged by the treating physician. • History of a severe seizure disorder or current anticonvulsant use • History of immunologically mediated disease, severe chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study • Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range) • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension • Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions. (Patients receiving Methadone or Subutex therapy may be included in this study.) • Inability or unwillingness to provide informed consent or abide by the requirements of the study • Male partners of women who are pregnant • Hemoglobin < 11.3 g/dL (< 7.0 mmol/L) in women or < 12.9 g/dL (< 8.0 mmol/L) in men at screening. • Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, etc) or for whom anemia would be medically problematic • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS®) combination therapy with ribavirin (Copegus®) given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA < 50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.;Secondary Objective: To prospectively evaluate: • the predictive value of monitoring of viral load at screening visit, day 0, day 6, day 13, day 27, week 8, week 12, week 24, for determining which patients will obtain a sustained virological response when treated with pegylated interferon combination therapy with ribavirin given for 24 or 48 weeks. To prospectively evaluate the association between the therapeutic efficacy of pegylated interferon combination therapy with ribavirin given for 24 or 48 weeks and: • non-invasive fibrosis indexes, e.g. APRI and GUCI • pretreatment blood, serum, and plasma factors (e.g. IP-10 anti-HBc, HBV-DNA, cholesterol and triglyceride levels) • adherence to therapy • trough ribavirin concentration day 13, day 27, week 8, week 12, and week 24 • body-mass index and waist measurement • cirrhosis (Ishak stage 5-6), bridging fibrosis (Ishak stage 3-4), significant fibrosis (Ishak stage 3-6), grade of inflammation, and steatosis grade in available liver biopsies ;Primary end point(s): SVR rate defined as percentage of patients with non-detectable HCV-RNA 24 weeks after completion of the 24 or 48 week treatment period. | — |
Countries
Denmark, Finland, Sweden
Outcome results
None listed