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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: June 23, 2008
Last updated: April 8, 2015
Last verified: April 2015
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.

Condition Intervention
Hepatitis C, Chronic
Hepatitis C
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen
Drug: Rebetol (ribavirin; SCH 18908)

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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey. [ Time Frame: The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment. ] [ Designated as safety issue: No ]
    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.

Enrollment: 185
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All Treated Patients
All patients participating in the study.
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen
PegIntron pen administered in accordance with approved labeling
Other Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling.
Other Name: SCH 18908


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with hepatitis C under treatment with PegIntron Pen plus Rebetol therapy at approximately 70 sites in Romania.

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704717     History of Changes
Other Study ID Numbers: P04301 
Study First Received: June 23, 2008
Results First Received: February 11, 2009
Last Updated: April 8, 2015
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2b
Anti-Infective Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016