Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)

The current gold standard for treatment of chronic hepatitis C is 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 PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepacivirus 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

Exclusion criteria

Not willing to participate in the study

Treatment and study plan

peginterferon alfa-2b (SCH 54031)

Biological

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

Other names: PegIntron, PegPen

Ribavirin (SCH 18908)

Drug

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

Other names: Rebetol

Primary outcomes

Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.

Time frame: After 4 weeks of treatment.

Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.

Sponsors and collaborators

Lead sponsor

Schering-Plough

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Jun 26, 2008
Registry last updated: Aug 25, 2009

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