Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)

Completed

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

• Registration Number: NCT00727259
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The current gold standard for treatment of chronic hepatitis C (CHC) patients is with 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 PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Detailed Description

Enrollment of patients will occur in a sequential order of treatment initiation.

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Results First Submitted: 2009-06-18
• Results First Submitted QC: 2009-06-18
• Results First Posted: 2009-08-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1995

Inclusion Criteria

• Adult patients with hepatitis C

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Exclusion Criteria

• According to the products' labeling.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic hepatitis C	Ribavirin (SCH 18908)	Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
Patients with chronic hepatitis C	Peginterferon alfa-2b (SCH 54031)	Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.

Primary Outcome Measures

Name	Time	Method
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months	The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.	Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).