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NCT03706222 Clinical Trial

Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

Drug Interaction Potentiation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03706222
Other study ID # MISP#57751
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2018
Est. completion date February 25, 2019

Study information
Verified date March 2019
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date February 25, 2019
Est. primary completion date February 25, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (2)
Lead Sponsor Collaborator
National Cheng-Kung University Hospital Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 the comorbid diseases of CHC patients in Taiwan Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment. Comorbid diseases will be assessed before elbasvir/grazoprevir treatment.
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