Surveillance for Antiviral Resistant Variants in Chronic... | NCT02065999

Studies
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

NCT02065999

Sponsor

Kirby Institute

Status

Completed

Last Update Posted

Mar 6, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Chronic Hepatitis C Infection

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012Actual

Primary Completion Date

Jun 2022Actual

Completion Date

Jun 2022Actual

First Submitted Date

Feb 16, 2014

First Submission Date that Met QC Criteria

Feb 18, 2014

First Posted Date

Feb 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2024

Last Update Posted Date

Mar 6, 2024Actual

Name	Class
The University of New South Wales	OTHER
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.
To determine whether in the absence of drug pressure there is variation in the prevalence of naturally occurring resistance associated variants.
To correlate the presence and frequency of baseline resistance-associated variants with the response to therapy with DAA-based triple therapy regimens for HCV.
To identify predictors of emergent DAA resistance and treatment failure during therapy with DAA-based combination strategies, including virological, clinical and immunological factors.
To characterize the natural history of HCV resistance associated variants that are selected during antiviral therapy after the withdrawal of treatment.
To establish a cohort of DAA-treatment failure patients suitable for re-treatment studies.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

An anticipated 100 participants will be recruited from 2 study sites: St Vincent's Hospital, Sydney; St Vincent's Hospital, Melbourne.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD	The University of New South Wales	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Vincent's Hospital		Sydney	New South Wales	2010	Australia
St Vincent's Hospital

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided