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OpenTrials
Completed

NCT Number: NCT03706222

Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

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.

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Key information

Conditions

Drug Interaction Potentiation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

elbasvir/grazoprevir

Drug

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

Other names: Zepatier

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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