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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1995

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.

Description

Inclusion Criteria:

• Adult patients with hepatitis C

Exclusion Criteria:

• According to the products' labeling.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic hepatitis C; Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.	Biological: Peginterferon alfa-2b (SCH 54031); Peginterferon alfa-2b will be administered according to the products' labeling.; Other Names: PegIntron; PegPen; Drug: Ribavirin (SCH 18908); Ribavirin will be administered according to the products' labeling.; Other Names: Rebetol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): April 1, 2008

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (ESTIMATE): August 1, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2b
• Other Study ID Numbers: P04067