Trial Outcomes & Findings for Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301) (NCT NCT00704717)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

185 participants

Primary outcome timeframe

The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.

Results posted on

2015-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	All Treated Patients All patients participating in the study.
Overall Study STARTED	185
Overall Study COMPLETED	185
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Treated Patients n=185 Participants All patients participating in the study.
Age, Continuous	49.18 years STANDARD_DEVIATION 9.94 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants
Region of Enrollment Romania	185 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Treated Patients n=182 Participants All patients participating in the study.
Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.	6.16 Units on a scale Standard Deviation 0.96

Adverse Events

All Treated Patients

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Treated Patients n=183 participants at risk All patients participating in the study.
General disorders Pyrexia	7.7% 14/183 • Number of events 20

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place