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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705263
• Other study ID #: P04244
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: August 20, 2009
• Start date: October 2005
• Est. completion date: May 2008

Study information

• Verified date: August 2009
• Source: Schering-Plough
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepacivirus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Schering-Plough

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.		After 4 weeks of treatment.	No