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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00723632 |
The objective of the study is to evaluate the costs associated with PegIntron plus Rebetol treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between HCV therapy-related costs with ribavirin dosing and patient history.
Condition | Intervention |
Hepatitis C, Chronic Hepatitis C |
Biological: PegIntron (peginterferon alfa-2b; peginterferon α-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908) |
MedlinePlus related topics: | Hepatitis Hepatitis C |
Drug Information available for: | Ribavirin Peginterferon Alfa-2b |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin |
Estimated Enrollment: | 500 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
Arm 1
All patients included in the study
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Biological: PegIntron (peginterferon alfa-2b; peginterferon α-2b; SCH 54031)
PegIntron administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for patients with HCV genotype 1 or for 24 weeks for patients with HCV genotype 2, 3.
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling, ie, 800 mg/day for patients <65 kg, 1000 mg/day for patients >65 to <85 kg, and 1200 mg/day for patients >=85 kg, administered orally for 48 weeks for patients with HCV genotype 1 or for 24 weeks for patients with HCV genotype 2, 3.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with chronic hepatitis C treated with PegIntron and Rebetol at approximately 81 sites in the Czech Republic.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04588 |
First Received: | July 25, 2008 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00723632 |
Health Authority: | Czech Republic: State Institute for Drug Control; Czech Republic: Ethics Committee |
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