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

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: NCT00705263
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : July 17, 2009
Last Update Posted : August 25, 2009
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hepacivirus Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia
Study Start Date : October 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients with chronic hepatitis C
Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Other Name: PegIntron, PegPen

Drug: Ribavirin (SCH 18908)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Other Name: Rebetol

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing to participate in the study

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Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough Identifier: NCT00705263     History of Changes
Other Study ID Numbers: P04244
First Posted: June 26, 2008    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: August 25, 2009
Last Verified: August 2009
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