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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704717
• Other study ID #: P04301
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: April 8, 2015
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031) pen
PegIntron pen administered in accordance with approved labeling

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.	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.	The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.	No