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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705263 |
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 |
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Hepatitis C, Chronic Hepacivirus |
Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908) |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia |
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 |
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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.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.
Inclusion Criteria:
Exclusion Criteria:
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 History of Changes |
Health Authority: | Slovenia: Agency for Medicinal Products - Ministry of Health |
Antimetabolites Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents |
Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents Liver Diseases Hepatitis, Chronic Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2b Interferon Alfa-2b Hepatitis C, Chronic |