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

April 8, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with hepatitis C under treatment with PegIntron Pen plus Rebetol therapy at approximately 70 sites in Romania.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Treated Patients
All patients participating in the study.
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen
PegIntron pen administered in accordance with approved labeling
Other Names:
  • SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling.
Other Names:
  • SCH 18908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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