Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.

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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

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 hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.

Exclusion criteria

Not applicable

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031) pen

Biological

PegIntron pen administered in accordance with approved labeling

Other names: SCH 54031

REBETOL (ribavirin; SCH 18908)

Drug

Rebetol administered in accordance with approved labeling.

Other names: SCH 18908

Primary outcomes

Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.

Time frame: The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.

The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.

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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Jun 25, 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