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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02065999
Registration number
NCT02065999
Ethics application status
Date submitted
16/02/2014
Date registered
19/02/2014
Date last updated
6/03/2024
Titles & IDs
Public title
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
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Scientific title
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
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Secondary ID [1]
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VHCRP1107
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Universal Trial Number (UTN)
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Trial acronym
SEARCH-C
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Infection
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.
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Assessment method [1]
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Descriptive statistics will be used to describe RAVs using standard international nomenclature and presented in table form. Baseline clinical and demographic data on subjects will be presented, as will rates of treatment failure and reasons for failure.
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Timepoint [1]
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Baseline
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Secondary outcome [1]
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Factors associated with treatment failure due to virological breakthrough / relapse.
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Assessment method [1]
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Multivariable logistic regression modelling with backwards elimination will be used to identify factors associated with this.
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Timepoint [1]
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Baseline
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Eligibility
Key inclusion criteria
* Chronic hepatitis C infection
* Commencing or expected to commence DAA-based HCV treatment within the next year
* IFN treatment-naïve or IFN treatment-experienced
* Provision of written, informed consent
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* In the opinion of the investigator that the patient is not able to provide informed consent
* Inability or unwillingness to comply with study collection requirements
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2022
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment hospital [2]
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St Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Kirby Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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Merck Sharp & Dohme LLC
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multi-centre prospective longitudinal cohort study with the aim of collecting and storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs for hepatitis C therapy.
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Trial website
https://clinicaltrials.gov/study/NCT02065999
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD
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Address
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The University of New South Wales
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02065999
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