A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | June 2010 |
Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)
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.
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.
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
We found this trial at
12
sites
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