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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Peginterferon via auto-injector device.

All participants will receive Peginterferon in a cross-over design.

Group Type EXPERIMENTAL

Autoinjector

Intervention Type DEVICE

Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.

2

Peginterferon via pre-filled syringe.

All participants will receive Peginterferon in a cross-over design.

Group Type ACTIVE_COMPARATOR

Pre-filled syringe

Intervention Type DEVICE

Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.

Interventions

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Autoinjector

Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.

Intervention Type DEVICE

Pre-filled syringe

Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No