Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)
NCT ID: NCT00728494
Last Updated: 2015-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
99 participants
OBSERVATIONAL
2005-10-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment and Patient Assistance Program
Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Patient Assistance Program
The patient assistance program includes the following:
* Training by physicians or specialized nurses.
* Informational materials based on the "To beat HCV" program.
* Management of specific side effects.
Treatment Alone
PegIntron/Rebetol treatment only.
PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Interventions
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PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Patient Assistance Program
The patient assistance program includes the following:
* Training by physicians or specialized nurses.
* Informational materials based on the "To beat HCV" program.
* Management of specific side effects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Only HCV genotype 1 infected patients will be enrolled in the study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P04671
Identifier Type: -
Identifier Source: org_study_id
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