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

Completed · Phase 1

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01087944

Run by

Hoffmann-La Roche

People needed

60

Starts

2010-03-01

Expected to finish

2010-06-01

Last updated by the study team

2016-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Framingham, Massachusetts, United States
• Study site — Newark, New Jersey, United States
• Study site — Vineland, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Poughkeepsie, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Columbia, South Carolina, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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