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This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3 weeks. Anticipated time on study treatment is 6 weeks. Target sample size is <100 patients.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Chronic Hepatitis C
peginterferon alfa-2a [Pegasys], autoinjector, pre-filled syringe
Published on BioPortfolio: 2014-07-23T21:09:49-0400
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INFLAMMATION of the LIVER with ongoing hepatocellular injury for 6 months or more, characterized by NECROSIS of HEPATOCYTES and inflammatory cell (LEUKOCYTES) infiltration. Chronic hepatitis can be caused by viruses, medications, autoimmune diseases, and other unknown factors.
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A closely related group of antigens found in the plasma only during the infective phase of hepatitis B or in virulent chronic hepatitis B, probably indicating active virus replication; there are three subtypes which may exist in a complex with immunoglobulins G.
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