Hepacivirus, Hepatitis C, Chronic
Conditions
Brief summary
The current gold standard for treatment of chronic hepatitis C is 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 PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.
Interventions
BIOLOGICALPeginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Sponsors
Schering-Plough
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol
Exclusion criteria
* Not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | After 4 weeks of treatment. | Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale. |
Participant flow
Pre-assignment details
113 patients were enrolled in the study; however, data were available for 110 subjects
Participants by arm
| Arm | Count |
|---|---|
| Patients With Chronic Hepatitis C Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Patients With Chronic Hepatitis C |
|---|---|
| Age Continuous | 40.25 years STANDARD_DEVIATION 12.71 |
| Region of Enrollment Slovenia | 110 participants |
| Sex/Gender, Customized Female | 37 participants |
| Sex/Gender, Customized Male | 68 participants |
| Sex/Gender, Customized Not provided | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / — |
| serious Total, serious adverse events | 0 / — |
Outcome results
Primary
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.
Time frame: After 4 weeks of treatment.
Population: Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Injection technique: correctly injected | 104 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | No difficulties injecting | 102 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Overall impression | 102 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Satisfaction with the pen | 102 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Ease of setting the dose | 101 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Ease of use of the pen | 101 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Convenience of use of the pen | 101 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Easy injection | 98 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Correct dose | 98 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Helpfulness of the brochure: instructions | 96 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Overall helpfullness of the brochure | 94 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Helpfulness of the brochure: advice | 91 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Helpfulness of the brochure: general information | 90 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Difficulty of preparing the pen | 90 Satisfied Participants |
| Patients Treated With PegIntron Pen Plus Rebetol | Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. | Time required to prepare the pen | 88 Satisfied Participants |