This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
272
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
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Birmingham, Alabama, United States
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La Jolla, California, United States
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Long Beach, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Percentage of Participants With at Least 1 Adverse Event
Time frame: From Baseline to the end of the study (up to 72 weeks)
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San Francisco, California, United States
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Aurora, Colorado, United States
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Gainesville, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
...and 57 more locations