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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00704717
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : June 2, 2009
Last Update Posted : April 29, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hepatitis C Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen Drug: Rebetol (ribavirin; SCH 18908)

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Study Type : Observational
Actual Enrollment : 185 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
Study Start Date : September 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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 Name: SCH 54031

Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling.
Other Name: SCH 18908

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with hepatitis C under treatment with PegIntron Pen plus Rebetol therapy at approximately 70 sites in Romania.

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00704717     History of Changes
Other Study ID Numbers: P04301
First Posted: June 25, 2008    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: April 29, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs