Phase 1
Completed N=60
A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01087944 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Feb 2016
Primary outcomePrimary: Feasibility of Peginterferon Alfa-2a Administration by Autoinjector — 11; 14; 49; 45 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Peginterferon Alfa-2a Administration by Autoinjector |
11; 14; 49; 45; 0; 3 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein |
1; 0; 3; 3; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Hematocrit |
1; 0; 3; 1 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil |
0; 0; 5; 3; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) |
1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR) |
0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase |
4; 4; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Creatinine |
0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure |
3; 4; 0; 0; 7; 10 | — |
| SECONDARY Number of Participants With Abnormalities in Electrocardiograms |
2; 2 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
34; 38 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01087944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.