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
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedMarch 13, 2019
March 1, 2019
4 months
October 8, 2018
March 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
the potential drug drug interaction of elbasvir/grazoprevor
the ratio of patients with at least one predicted DDI will be analyzed.
DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment
Secondary Outcomes (1)
the comorbid diseases of CHC patients in Taiwan
Comorbid diseases will be assessed before elbasvir/grazoprevir treatment.
Study Arms (1)
Drug interaction of Elbasvir/Grazoprevir
Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.
Interventions
Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
Eligibility Criteria
Patients infected with genotype 1 or 4 hepatitis C virus and treated with elbasvir/grazoprevir during August 2017 to July 2018 in Taiwan.
You may qualify if:
- Patients treated with grazoprevir/elbasvir are candidates of study subjects.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cheng-Kung University Hospitallead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Related Publications (1)
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.
PMID: 31594667DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Pin-Nan Cheng, M.D.
National Cheng-Kung University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 8, 2018
First Posted
October 15, 2018
Study Start
October 22, 2018
Primary Completion
February 25, 2019
Study Completion
February 25, 2019
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share