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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients with hepatitis C

Exclusion criteria

According to the products' labeling.

Treatment and study plan

peginterferon alfa-2b (SCH 54031)

Biological

Peginterferon alfa-2b will be administered according to the products' labeling.

Other names: PegIntron, PegPen

Ribavirin (SCH 18908)

Drug

Ribavirin will be administered according to the products' labeling.

Other names: Rebetol

Primary outcomes

Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: SATISFACTION

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Aug 1, 2008
Registry last updated: Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed