Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan
NCT ID: NCT03706222
Last Updated: 2019-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2018-10-22
2019-02-25
Brief Summary
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Detailed Description
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DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of comidications: Category 0: Classification not possible due to lack of information; Category 1: No clinical interaction possible; Category 2: May require dose adjustment/closer monitoring; Category 3: Coadministration not recommended or contraindicated.
The assessment of DDI will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant DDI, and the ratio of patients with at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Drug interaction of Elbasvir/Grazoprevir
Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.
elbasvir/grazoprevir
Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
Interventions
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elbasvir/grazoprevir
Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
National Cheng-Kung University Hospital
OTHER
Responsible Party
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Pin-Nan Cheng
Associate Professor
Principal Investigators
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Pin-Nan Cheng, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cheng-Kung University Hospital
Locations
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National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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Liu CJ, Tseng KC, Lo CC, Tseng IH, Cheng PN. Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. J Formos Med Assoc. 2020 May;119(5):933-940. doi: 10.1016/j.jfma.2019.09.011. Epub 2019 Oct 5.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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MISP#57751
Identifier Type: -
Identifier Source: org_study_id
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