Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)(COMPLETED) - Full Text View

Purpose

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)

MedlinePlus related topics:

Hepatitis Hepatitis C

ChemIDplus related topics:

Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Satisfaction of patients receiving PegIntron pen plus Rebetol therapy, assessed by a survey. [ Time Frame: The survey will be administered when the patient returns for a follow-up visit in the clinic, after using the Pen for several weeks. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	160
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
Arm 1 All patients participating in the study.	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.

Eligibility

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Not applicable

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04301
First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704717
Health Authority:	Romania: National Medicines Agency

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Ribavirin

Peginterferon alfa-2b

Hepatitis, Viral, Human

Hepatitis C

Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704717