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

Hepatitis C, Chronic Clinical Trial

— SATISFACTION  

Official title:

Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727259
• Other study ID #: P04067
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: April 7, 2015
• Start date: October 2004
• Est. completion date: April 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Not Applicable
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1995
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with hepatitis C

Exclusion Criteria:

• According to the products' labeling.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b will be administered according to the products' labeling.

Drug:
• Ribavirin (SCH 18908)
Ribavirin will be administered according to the products' labeling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months	Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).	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.	No