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Trial record 1 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR
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Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706222
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pin-Nan Cheng, National Cheng-Kung University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Drug Interaction Potentiation Drug: elbasvir/grazoprevir

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.


Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Groups and Cohorts
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Group/Cohort Intervention/treatment
Drug interaction of Elbasvir/Grazoprevir
Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.
 Drug: elbasvir/grazoprevir
Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
Other Name: Zepatier


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients infected with genotype 1 or 4 hepatitis C virus and treated with elbasvir/grazoprevir during August 2017 to July 2018 in Taiwan.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Pin-Nan Cheng, M.D. National Cheng-Kung University Hospital
  Study Documents (Full-Text)

Documents provided by Pin-Nan Cheng, National Cheng-Kung University Hospital:
Study Protocol  [PDF] July 28, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pin-Nan Cheng, Associate Professor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03706222     History of Changes
Other Study ID Numbers: MISP#57751
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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MK-5172
Antiviral Agents
Anti-Infective Agents