Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.
Interventions
BIOLOGICALPegIntron (peginterferon alfa-2b; SCH 54031) pen
PegIntron pen administered in accordance with approved labeling
Rebetol administered in accordance with approved labeling.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey. | The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment. | The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Treated Patients All patients participating in the study. | 185 |
| Total | 185 |
Baseline characteristics
| Characteristic | All Treated Patients |
|---|---|
| Age, Continuous | 49.18 years STANDARD_DEVIATION 9.94 |
| Region of Enrollment Romania | 185 participants |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 183 |
| serious Total, serious adverse events | 0 / 183 |
Outcome results
Primary
Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.
The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.
Time frame: The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treated Patients | Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey. | 6.16 Units on a scale | Standard Deviation 0.96 |