Hepatitis C, Chronic
Conditions
Brief summary
The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.
Detailed description
Enrollment of patients will occur in a sequential order of treatment initiation.
Interventions
BIOLOGICALPeginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b will be administered according to the products' labeling.
Ribavirin will be administered according to the products' labeling.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with hepatitis C
Exclusion criteria
* According to the products' labeling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment. | Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied). |
Participant flow
Pre-assignment details
Enrolled: 1995 subjects; all questionnaires were returned for 940 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Chronic Hepatitis C Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940). | 940 |
| Total | 940 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not all questionnaires completed | 1,055 |
Baseline characteristics
| Characteristic | Patients With Chronic Hepatitis C |
|---|---|
| Age, Continuous | 47.50 years STANDARD_DEVIATION 12.34 |
| Region of Enrollment France | 940 Participants |
| Sex/Gender, Customized Female | 323 Participants |
| Sex/Gender, Customized Male | 616 Participants |
| Sex/Gender, Customized Missing data | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).
Time frame: The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.
Population: Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| After 1 Month of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Ease of preparation of the Pen | 5.48 satisfaction rating from 0-7 | Standard Deviation 1.74 |
| After 1 Month of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Simplicity of adjustment of the injected dose | 5.74 satisfaction rating from 0-7 | Standard Deviation 1.71 |
| After 1 Month of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Time required for the preparation of the injection | 5.49 satisfaction rating from 0-7 | Standard Deviation 1.52 |
| After 1 Month of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Ease of injection | 5.89 satisfaction rating from 0-7 | Standard Deviation 1.46 |
| After 1 Month of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Characteristics of the needle | 6.14 satisfaction rating from 0-7 | Standard Deviation 1.25 |
| After 1 Month of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Overall satisfaction with the system of injection | 5.99 satisfaction rating from 0-7 | Standard Deviation 1.73 |
| After 3 Months of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Characteristics of the needle | 6.25 satisfaction rating from 0-7 | Standard Deviation 1.21 |
| After 3 Months of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Ease of preparation of the Pen | 5.91 satisfaction rating from 0-7 | Standard Deviation 1.41 |
| After 3 Months of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Ease of injection | 6.00 satisfaction rating from 0-7 | Standard Deviation 1.37 |
| After 3 Months of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Simplicity of adjustment of the injected dose | 6.08 satisfaction rating from 0-7 | Standard Deviation 1.41 |
| After 3 Months of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Overall satisfaction with the system of injection | 6.04 satisfaction rating from 0-7 | Standard Deviation 1.32 |
| After 3 Months of Treatment | Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months | Time required for the preparation of the injection | 5.84 satisfaction rating from 0-7 | Standard Deviation 1.32 |