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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00705263
First received: June 23, 2008
Last updated: August 20, 2009
Last verified: August 2009
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: October 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing to participate in the study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00705263     History of Changes
Other Study ID Numbers: P04244
Study First Received: June 23, 2008
Results First Received: May 28, 2009
Last Updated: August 20, 2009
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Hepatitis
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
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013