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

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Roche

Status and phase

Completed
Phase 1

Conditions

Hepatitis C, Chronic

Treatments

Device: Autoinjector
Device: Pre-filled syringe

Study type

Interventional

Funder types

Industry

Identifiers

NCT01087944
NP25154

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

60 participants in 2 patient groups

1
Experimental group
Description:
Peginterferon via auto-injector device. All participants will receive Peginterferon in a cross-over design.
Treatment:
Device: Autoinjector
2
Active Comparator group
Description:
Peginterferon via pre-filled syringe. All participants will receive Peginterferon in a cross-over design.
Treatment:
Device: Pre-filled syringe

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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