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 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Device: autoinjector
Device: pre-filled syringe
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Feasibility of peginterferon alfa-2a administration by autoinjector [ Time Frame: assessed weekly at time of injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Autoinjector
Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly for 6 weeks
Device: autoinjector
disposable autoinjector filled with 180mcg peginterferon alfa-2a, applied once a week for 3 weeks
Active Comparator: 2
pre-filled syringe
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087944

Locations
United States, California
Los Angeles, California, United States, 90045
United States, Florida
Bradenton, Florida, United States, 34209
Orlando, Florida, United States, 32803
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Massachusetts
Framingham, Massachusetts, United States, 01702
United States, New Jersey
Newark, New Jersey, United States, 07102
Vineland, New Jersey, United States, 08360
United States, New York
New York, New York, United States, 10016
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Asheville, North Carolina, United States, 28801
United States, South Carolina
Columbia, South Carolina, United States, 29204
United States, Texas
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01087944     History of Changes
Other Study ID Numbers: NP25154
Study First Received: March 9, 2010
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014