Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705263

Purpose

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.

Condition	Intervention
Hepatitis C, Chronic Hepacivirus	Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Patients' perception of the PegPen device accuracy and their usage of the PegPen in determining the user friendliness of the device. [ Time Frame: Patients treated with the PegPen will answer questions on the patient questionnaire at the first follow-up visit, after using the PegPen for several weeks. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	113
Study Start Date:	October 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with chronic hepatitis C Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.

Criteria

Inclusion Criteria:

Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

Exclusion Criteria:

Not willing to participate in the study

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04244
Study First Received:	June 23, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00705263
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009