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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03776760
Other study ID # VHCRP1802
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 28, 2019
Est. completion date August 2022

Study information

Verified date April 2022
Source Kirby Institute
Contact Gerard Estivill
Phone +612 9385 0900
Email gestivill@kirby.unsw.edu.au
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.


Description:

SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older; - voluntarily signed the informed consent form. Exclusion Criteria: - Pregnant women.

Study Design


Intervention

Device:
Fingerstick GeneXpert HCV RNA quantitative assay
All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly
Drug:
sofosbuvir/velpatesvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
glecaprevir/pibrentasvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Locations

Country Name City State
Australia Jullums Lismore Aboriginal Medical Service Lismore New South Wales
Australia Pangula Mannamurna Aboriginal Corporation Mount Gambier South Australia
Australia Port Lincoln Aboriginal Health Service Port Lincoln South Australia
Australia Walhallow Aboriginal Corporation Quirindi New South Wales

Sponsors (3)

Lead Sponsor Collaborator
Kirby Institute Flinders University, South Australian Health and Medical Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other HCV Transmission networks within the Aboriginal community HCV viral genome for will be sequenced for all participants from their screening sample. The sequences ill be used for develop a phylogenetic tree which can be used to determine transmission networks within the study population. At screening for all participants
Primary Change in Hepatitis C prevalence Change in the proportion of people with current HCV infection (HCV RNA positive) Week 0 to week 144
Secondary Change in Hepatitis C incidence Change in HCV incidence will be calculated using person-time of observation. Week 0 to week 144
Secondary DAA uptake Proportion with HCV infection initiating DAA therapy To week 144
Secondary Treatment response rate (SVR12 rate) Overall SVR12 rate in those who commence treatment From week 0 to Week 144
Secondary HCV reinfection incidence post treatment Participants will be assessed six monthly post end of treatment for HCV recurrence. 6 monthly from end of treatment until week 144
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