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

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ClinicalTrials.gov Identifier: NCT02065999
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
The University of New South Wales
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kirby Institute

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
Chronic Hepatitis C Infection

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Study Start Date : November 2012
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy. [ Time Frame: 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. [ Time Frame: Baseline ]
    Multivariable logistic regression modelling with backwards elimination will be used to identify factors associated with this.


Biospecimen Retention:   Samples With DNA
Stored serum and peripheral blood mononuclear cells.


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An anticipated 100 participants will be recruited from 2 study sites: St Vincent's Hospital, Sydney; St Vincent's Hospital, Melbourne.
Criteria

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

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): NCT02065999


Contacts
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Contact: Amanda Erratt +61 2 9385 0882 aerratt@kirby.unsw.edu.au
Contact: Pip Marks, BSc MPH (Hons) +61 2 9385 0886 pmarks@kirby.unsw.edu.au

Locations
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Australia, New South Wales
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Dianne How Chow    +612 8382 3607    dhowchow@stvincents.com.au   
Principal Investigator: Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD         
Australia, Victoria
St Vincent's Hospital Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Alex Dr Thompson, MBBS, FRACP, PhD    +61 3 9288 3580    Alexander.THOMPSON@svhm.org.au   
Principal Investigator: Alex Dr Thompson, MBBS, FRACP, PhD         
Sponsors and Collaborators
Kirby Institute
The University of New South Wales
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD The University of New South Wales

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02065999     History of Changes
Other Study ID Numbers: VHCRP1107
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by Kirby Institute:
Hepatitis C, chronic

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents