This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Mayo Clinic
Phoenix, Arizona, United States
University of Florida CRC
Gainesville, Florida, United States
University of Florida at Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.
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Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Duke University
Durham, North Carolina, United States
Metropolitan Research
Fairfax, Virginia, United States