Chronic Hepatitis C MedDRA version: 9.1 Level: HLT Classification code 10019715 Term: Hepatic viral infections
Conditions
Interventions
Trade Name: PEGINTRON
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Peginterferon alfa-2b
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type:
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age over 18 years; -HCVAb positivity (ELISA third generation test); -HCVRNA detected with a sensitive polimerase chain reaction (PCR) technique (cut-off=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Ipersensibility to interferon or ribavirin -pregnancy or breast feeding -Clinical history of cardiac failure, severe psichiatric disease, seizure, tyroid not compensated disease, any other severe chronic disease in sperimentator's opinion -Autoimmune hepatitis -decompenstaed liver failure -Hb<11g/dL in women and <12g/dL in men -Neutrophil count<1500/mmc -platelet count <90000/mmc -creatinine level<1.5 upper limit of normal range -Severe retinopathy For HIVAb+ patients: -opportunistic infection or neoplastic malignancy -concomitant antiretroviral theraoy with AZt or d4T or ddI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: STUDY OBJECTIVES: Primary study objectives of the ARNICA project are the following: -To evaluate factors influencing patients willingness to access therapeutic program for chronic hepatitis C (CHC) and -To evaluate efficacy, safety and adherence of antiviral treatment for CHC with pegylated interferon (PEG-IFN) alfa 2b plus ribavirin (RBV) in patients with active substance use dependence and/or in substitution or support therapy.;Secondary Objective: Tolerability and security of antiviral therapy with PEG-IFN and RBV; -Adherence to antiviral treatment; -Prevalence of HBV infection and its role in influencing antivaral therapy for CHC; -Prevalence of HIV coinfection and its impact on response to antiviral therapy for HCV; -Prevalence of HAVAb IgG; -Impact of HCVAb screening on alcohol consumption. ARNICA project has the porpouse to offer an HBV and HAV vaccination program among IDUs with CHC, without protection against these two hepatotrophic viruses.;Primary end point(s): efficacy of antiviral therapy with PEG-IFN and RBV will be evaluated as rate of Sustained Virologic Response (SVR) indicated by undetectable levels of HCVRNA [limit of detection of 50 IU/ml] 24 weeks after treatment termination. | — |
Countries
Italy
Outcome results
None listed