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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02065999




Registration number
NCT02065999
Ethics application status
Date submitted
16/02/2014
Date registered
19/02/2014
Date last updated
6/03/2024

Titles & IDs
Public title
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Scientific title
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Secondary ID [1] 0 0
VHCRP1107
Universal Trial Number (UTN)
Trial acronym
SEARCH-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Factors associated with treatment failure due to virological breakthrough / relapse.
Timepoint [1] 0 0
Baseline

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2022
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Merck Sharp & Dohme LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02065999
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02065999