Chronic Hepatitis C InfectionSEARCH-CNCT02065999
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
An observational study of Chronic Hepatitis C Infection, run by Kirby Institute at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Hepatitis C Infection
- How many people
- 100 participants
- Where
- 2 sitesAustralia
- Study dates
- Nov 2012to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An anticipated 100 participants will be recruited from 2 study sites: St Vincent's Hospital, Sydney; St Vincent's Hospital, Melbourne.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
St Vincent's Hospital
Melbourne, Victoria, 3065
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
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.
Read the 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.
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- Hepatitis C, chronic
- Medical subject headings
- Hepatitis C, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD, Principal investigator, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065999
- Sponsor's protocol ID
- VHCRP1107
- Acronym
- SEARCH-C
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2014
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT02065999
- Acronym / sponsor ID
- SEARCH-C / VHCRP1107
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- Hepatitis C, chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales, Merck Sharp & Dohme LLC
- Study start
- Nov 2012 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An anticipated 100 participants will be recruited from 2 study sites: St Vincent's Hospital, Sydney; St Vincent's Hospital, Melbourne.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Factors associated with treatment failure due to virological breakthrough / relapse.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD principal investigator
The University of New South Wales
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C Infection, run by Kirby Institute at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.