A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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