None listed
Conditions
Interventions
Group A Type of group
PEG-IFN 1 or 0.5 mL, administered subcutaneously once a week as monotherapy
PEG-IFN 1 or 0.5 mL, administered subcutaneously once a week plus ribavirin 800 mg per day, administered orally in divided doses, treatment period, 48 weeks
Follow-up period, 24 weeks
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male patients and women> 18 years of age • Serological evidence of chronic hepatitis C infection, using a test to detect anti-HCV antibodies • HCV RNA detectable in the serum • Elevated ALT serum activity • Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliac patients, in whom the biopsy is medically contraindicated, do not require such a procedure) • Compensated liver disease (Grade A according to the Child-Pugh clinical classification) • Negative test for pregnancy in the urine or blood (for women with fertile potential), documented during the 24-hour period before receiving the first dose of the study drug • All fertile men and women receiving ribavirin should use two forms of effective contraception during treatment and for 6 months after the end of treatment
Exclusion criteria
Exclusion criteria: • Pregnant or nursing women • Systemic therapy with an antineoplastic or immunomodulatory treatment (including supraphysiological doses of steroids and radiation) 1.5 times the upper limit of normality in the selection • History of severe psychiatric illness, especially depression. Severe psychiatric illness is defined as treatment with an antidepressant medication or with a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time; or any history of the following: a suicide attempt, hospitalization because of a psychiatric illness, or a period of disability due to a psychiatric illness • History of a severe seizure disorder or habitual use of anticonvulsants • History of any immunologically mediated disease, chronic lung disease associated with any functional limitation, severe heart disease, transplantation of major organs or other evidence of severe disease, malignancy or any other condition that could, in the opinion of the investigator, cause the patient not to be appropriate to be included in the study • History of poorly controlled thyroid disease with prexrita medications, high concentrations of thyroid stimulating hormone (TSH), with elevation in antibodies against thyroid peroxidase and any clinical manifestation of thyroid disease • Evidence of severe retinopathy (eg, cytomegalovirus retinitis (CMV, macular degeneration) • Evidence of drug abuse (including excessive alcohol consumption) within one year of entering the study • Inability or refusal to offer informed consent or not to accept the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An Adverse Event is any unexpected medical occurrence in a patient or in a subject of a clinical investigation to which a pharmaceutical product was administered and which does not necessarily have any causal relationship with said treatment. Measure:Frequency and profile of adverse events. Timepoints:48 weeks | — |
Outcome results
None listed