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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,695
800 - 1200 mg po daily for 24 weeks
800 - 1200 mg po daily for 48 weeks
180 mcg sc once weekly for 24 weeks
180 mcg sc once weekly for 48 weeks
Unnamed facility
Afula, Israel
Unnamed facility
Ashkelon, Israel
Unnamed facility
Bat Yam, Israel
Unnamed facility
Beersheba, Israel
Unnamed facility
Hadera, Israel
Unnamed facility
Haifa, Israel
Unnamed facility
Haifa, Israel
Unnamed facility
Haifa, Israel
Unnamed facility
Holon, Israel
Unnamed facility
Jerusalem, Israel
...and 10 more locations
safety and tolerability with regard to clinical AEs and laboratory parameters
Time frame: assessed every 2 weeks throughout study and after 8 weeks follow-up
safety with regard to hematological parameters
Time frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
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