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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02065999
Other study ID # VHCRP1107
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2012
Est. completion date June 2022

Study information

Verified date March 2024
Source Kirby Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Australia St Vincent's Hospital Melbourne Victoria
Australia St Vincent's Hospital Sydney New South Wales

Sponsors (3)

Lead Sponsor Collaborator
Kirby Institute Merck Sharp & Dohme LLC, The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy. 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. Baseline
Secondary Factors associated with treatment failure due to virological breakthrough / relapse. Multivariable logistic regression modelling with backwards elimination will be used to identify factors associated with this. Baseline
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