Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)
SATISFACTION
1 other identifier
observational
1,995
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2004
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 1, 2008
CompletedResults Posted
Study results publicly available
August 6, 2009
CompletedApril 29, 2015
April 1, 2015
3.5 years
July 30, 2008
June 18, 2009
April 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Patients with chronic hepatitis C
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
Interventions
Peginterferon alfa-2b will be administered according to the products' labeling.
Ribavirin will be administered according to the products' labeling.
Eligibility Criteria
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.
You may qualify if:
- Adult patients with hepatitis C
You may not qualify if:
- According to the products' labeling.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Clinical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 1, 2008
Study Start
October 1, 2004
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 29, 2015
Results First Posted
August 6, 2009
Record last verified: 2015-04