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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01087944
First received: March 9, 2010
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
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.
| 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
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: | May 23, 2013 |
| 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 May 23, 2013