Hepatitis C, Chronic
Conditions
Brief summary
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.
Interventions
800 - 1200 mg po daily for 24 weeks
DRUGpeginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability with regard to clinical AEs and laboratory parameters | assessed every 2 weeks throughout study and after 8 weeks follow-up |
Secondary
| Measure | Time frame |
|---|---|
| safety with regard to hematological parameters | assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up |
Countries
Israel
Outcome results
None listed