Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan
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|ClinicalTrials.gov Identifier: NCT03706222|
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment|
|Drug Interaction Potentiation||Drug: elbasvir/grazoprevir|
This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of study subjects. All the required study information will be recorded with detailed chart review.
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.
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan|
|Actual Study Start Date :||October 22, 2018|
|Actual Primary Completion Date :||February 25, 2019|
|Actual Study Completion Date :||February 25, 2019|
Drug interaction of Elbasvir/Grazoprevir
Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.
Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
Other Name: Zepatier
- the potential drug drug interaction of elbasvir/grazoprevor [ Time Frame: DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment ]the ratio of patients with at least one predicted DDI will be analyzed.
- the comorbid diseases of CHC patients in Taiwan [ Time Frame: Comorbid diseases will be assessed before elbasvir/grazoprevir treatment. ]Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706222
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|
|Principal Investigator:||Pin-Nan Cheng, M.D.||National Cheng-Kung University Hospital|