At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)
In Brief
A Phase 1 clinical trial evaluating Autoinjector and Pre-filled syringe for Hepatitis C, Chronic. Completed, enrolled 60 participants across 12 sites.
Detailed Summary
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 Details
Timeline
Interventions
Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.
Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.