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

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

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)

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

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 was administered during a follow-up visit in the clinic, at any point during the 48-week treatment. ] [ Designated as safety issue: No ]

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

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

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
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, 2009
Health Authority:	Romania: National Medicines Agency

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012