Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)

Completed

• Conditions: Hepatitis C, Chronic; Hepacivirus
• Interventions: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

• Registration Number: NCT00705263
• Lead Sponsor: Schering-Plough

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-26
• Results First Submitted: 2009-05-28
• Results First Submitted QC: 2009-05-28
• Results First Posted: 2009-07-17
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

Exclusion Criteria

• Not willing to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic hepatitis C	Peginterferon alfa-2b (SCH 54031)	Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
Patients with chronic hepatitis C	Ribavirin (SCH 18908)	Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.

Primary Outcome Measures

Name	Time	Method
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.