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Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03706222
Enrollment
400
Registered
2018-10-15
Start date
2018-10-22
Completion date
2019-02-25
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interaction Potentiation

Brief summary

Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.

Detailed description

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.

Interventions

Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients treated with grazoprevir/elbasvir are candidates of study subjects.

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
the potential drug drug interaction of elbasvir/grazoprevorDDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatmentthe ratio of patients with at least one predicted DDI will be analyzed.

Secondary

MeasureTime frameDescription
the comorbid diseases of CHC patients in TaiwanComorbid diseases will be assessed before elbasvir/grazoprevir treatment.Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026