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

Completed

• Conditions: Hepatitis C, Chronic; Hepatitis C
• Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen; Drug: Rebetol (ribavirin; SCH 18908)

• Registration Number: NCT00704717
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Results First Submitted: 2009-02-11
• Results First Submitted QC: 2009-04-08
• Results First Posted: 2009-06-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Treated Patients	PegIntron (peginterferon alfa-2b; SCH 54031) pen	All patients participating in the study.
All Treated Patients	Rebetol (ribavirin; SCH 18908)	All patients participating in the study.

Primary Outcome Measures

Name	Time	Method
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.