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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705107 |
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Condition | Intervention |
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Hepatitis C, Chronic Hepatitis C |
Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908) |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C |
Enrollment: | 350 |
Study Start Date: | November 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Arm 1
All patients participating in the study
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Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling.
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04247 |
Study First Received: | June 23, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00705107 History of Changes |
Health Authority: | Romania: National Medicines Agency |
Antimetabolites Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Peginterferon alfa-2b Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Hepatitis, Chronic Ribavirin Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Peginterferon alfa-2b Hepatitis C Hepatitis C, Chronic |