Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
SEARCH-C
1 other identifier
observational
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMarch 6, 2024
March 1, 2024
9.6 years
February 16, 2014
March 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
Factors associated with treatment failure due to virological breakthrough / relapse.
Baseline
Eligibility Criteria
An anticipated 100 participants will be recruited from 2 study sites: St Vincent's Hospital, Sydney; St Vincent's Hospital, Melbourne.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
- The University of New South Walescollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
Biospecimen
Stored serum and peripheral blood mononuclear cells.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD
The University of New South Wales
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2014
First Posted
February 19, 2014
Study Start
November 1, 2012
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
March 6, 2024
Record last verified: 2024-03