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NCT00705263 Clinical Trial

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
Secondary ID
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

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
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