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A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C - NCT01087944-32803(Clinical Trial 619554)



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City:  Orlando
State:  
FL
Zip Code: 32803
Conditions: Chronic Hepatitis C
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - adult patients, >/=18 years of age - chronic hepatitis C - on treatment with peginterferon alfa-2a for >/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a Exclusion Criteria: - history or evidence of decompensated liver disease - autoimmune hepatitis - hypersensitivity to peginterferon alfa-2a or any of its components - concomitant treatment that requires administration by self-injection, or prior use of an autoinjector
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Data Source: ClinicalTrials.gov
Date Processed: October 8, 2010
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