Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)
NCT ID: NCT01544582
Last Updated: 2016-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
713 participants
OBSERVATIONAL
2012-05-31
2015-07-31
Brief Summary
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As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.
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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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Boceprevir + PR
CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
No interventions assigned to this group
Telaprevir + PR
CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
No interventions assigned to this group
PR Alone
CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Untreated or failed previous therapy
* Initiated a new treatment regimen after the study implementation date at their site
* Agrees to participate in the study by giving written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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EP08043.001
Identifier Type: OTHER
Identifier Source: secondary_id
SCH 503034 P08518
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3034-072
Identifier Type: OTHER
Identifier Source: secondary_id
P08518
Identifier Type: -
Identifier Source: org_study_id
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