NCT01087944

A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C

Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DEVICE	Autoinjector	Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.
DEVICE	Pre-filled syringe	Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-03-16
• Last updated: 2016-02-09
• Results posted: 2016-02-09

Locations

12 sites across 1 country: United States