SEARCH-C: Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

Sponsor
Kirby Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT02065999
Collaborator
The University of New South Wales (Other), Merck Sharp & Dohme LLC (Industry)
100
2
124.9
50
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. To analyse for resistance-associated HCV variants in DAA-naïve HCV patients using population and ultra-deep pyrosequencing (UDPS). Resistance associated variants will be analysed by qualitative and quantitative methods both pre-treatment and on-treatment.

    2. To determine whether in the absence of drug pressure there is variation in the prevalence of naturally occurring resistance associated variants.

    3. To correlate the presence and frequency of baseline resistance-associated variants with the response to therapy with DAA-based triple therapy regimens for HCV.

    4. To identify predictors of emergent DAA resistance and treatment failure during therapy with DAA-based combination strategies, including virological, clinical and immunological factors.

    5. To characterize the natural history of HCV resistance associated variants that are selected during antiviral therapy after the withdrawal of treatment.

    6. To establish a cohort of DAA-treatment failure patients suitable for re-treatment studies.

    7. To establish a tissue repository of serum and PBMCs from well-characterized patients treated with DAA-based triple therapy to allow future examination of the role of other variables that may potentially impact on the outcomes of DAA based therapy and development of RAVs.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
    Actual Study Start Date :
    Nov 1, 2012
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy. [Baseline]

      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.

    Secondary Outcome Measures

    1. Factors associated with treatment failure due to virological breakthrough / relapse. [Baseline]

      Multivariable logistic regression modelling with backwards elimination will be used to identify factors associated with this.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Vincent's Hospital Sydney New South Wales Australia 2010
    2 St Vincent's Hospital Melbourne Victoria Australia 3065

    Sponsors and Collaborators

    • Kirby Institute
    • The University of New South Wales
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD, The University of New South Wales

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kirby Institute
    ClinicalTrials.gov Identifier:
    NCT02065999
    Other Study ID Numbers:
    • VHCRP1107
    First Posted:
    Feb 19, 2014
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Kirby Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022