A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- adult patients >/= 18 years of age
- serologic evidence of chronic hepatitis C infection
- compensated liver disease
- negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
Exclusion criteria
- history or other evidence of a medical condition associated with chronic liver disease other than HCV
- hepatitis A, hepatitis B or HIV infection
- hepatocellular carcinoma
- severe concomitant disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,695 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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