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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01087944
First received: March 9, 2010
Last updated: August 26, 2014
Last verified: August 2014

March 9, 2010
August 26, 2014
March 2010
June 2010   (final data collection date for primary outcome measure)
Feasibility of peginterferon alfa-2a administration by autoinjector [ Time Frame: assessed weekly at time of injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01087944 on ClinicalTrials.gov Archive Site
  • Safety and tolerability: Adverse events, laboratory parameters, ECG [ Time Frame: throughout study, laboratory assessments and ECG weeks 1, 4 and 6 ] [ Designated as safety issue: No ]
  • ease of handling of autoinjector versus pre-filled syringe, assessed by staff and patient [ Time Frame: weekly at time of injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a [Pegasys] by autoinjector versu s pre-filled syringe in patients with chronic hepatitis C, either on treatment w ith peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterf eron alfa-2a. Patients will be randomized to self-injection of 180mcg peginterfe ron 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. A nticipated time on study treatment is 6 weeks. Target sample size is <100 patien ts.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Device: autoinjector
    disposable autoinjector filled with 180mcg peginterferon alfa-2a, applied once a week for 3 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180mcg sc weekly for 6 weeks
  • Device: pre-filled syringe
    pre-filled syringe with 180mcg peginterferon alfa 2a, applied once a week for 3 weeks
  • Experimental: 1
    Autoinjector
    Interventions:
    • Device: autoinjector
    • Drug: peginterferon alfa-2a [Pegasys]
  • Active Comparator: 2
    pre-filled syringe
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Device: pre-filled syringe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01087944
NP25154
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP