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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/NCT02555475




Registration number
NCT02555475
Ethics application status
Date submitted
17/09/2015
Date registered
21/09/2015
Date last updated
24/05/2018

Titles & IDs
Public title
The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital
Scientific title
The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial
Secondary ID [1] 0 0
HREC/15/SVHM/41
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 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
Interventional
Description of intervention(s) / exposure
Other interventions - community based hepatitis C care and treatment

No Intervention: Group 1, tertiary hospital based care - Group 1: (n=190) Following their initial screen, these participants will be referred to a tertiary hospital for hepatitis C care, transient elastography and DAA treatment (traditional / standard model of care).

Experimental: Group 2, community based care - Group 2: (n=190) Following their initial screen, these participants will be offered community based hepatitis C care and treatment. Hepatitis C care, transient elastography and DAA treatment will be delivered at the primary healthcare centre only.


Other interventions: community based hepatitis C care and treatment
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To measure the proportion of people attending at a Primary Health Care Service for their genotype 1 HCV infection who commence antiviral treatment (Viekira Pak and ribavirin) and have a SVR 12.
Timepoint [1] 0 0
Sustained virology response (SVR) rates at week 12 post treatment.
Secondary outcome [1] 0 0
To measure the proportion of people attending a PHCS with G1 HCV infection who commence antiviral treatment (Viekira Pak and ribavirin) if they are managed at a PHCS compared to those who are referred to and managed at a tertiary hospital.
Timepoint [1] 0 0
Treatment uptake within 8 weeks of randomisation
Secondary outcome [2] 0 0
To measure the proportion of people with G1 HCV who have an SVR12 at a PHCS compared a tertiary hospital.
Timepoint [2] 0 0
SVR rate at week 12 post treatment
Secondary outcome [3] 0 0
To measure the reduction in HCV viraemia (community viral load) among participants considering retention through the cascade of care and SVR12.
Timepoint [3] 0 0
up to 24 weeks post treatment
Secondary outcome [4] 0 0
To measure the cost effectiveness of managing and treating people in a primary health service compared to a tertiary hospital.
Timepoint [4] 0 0
up to 24 weeks post treatment
Secondary outcome [5] 0 0
To define the cascade of care for patients referred to a community hepatitis nurse for assessment of HCV.
Timepoint [5] 0 0
up to 12 weeks post treatment

Eligibility
Key inclusion criteria
- Aged =18 years;

- Attendance at a study PHCS defined as; Attended appointment at PHCS at least once in
2014 or; Attended at least one consultation with a study community hepatitis nurse
between 2012-2014

- Evidence of chronic G1 HCV infection (HCV antibody positive for > 6 months and HCV RNA
positive);

- Absence of cirrhosis defined as one of the following:

Liver biopsy within 24 months prior to screening demonstrating absence of cirrhosis (e.g. a
Metavir score of 3 or less or an Ishak score of 4 or less); or A screening FibroScan result
of <9.6 kPa; or if a FibroScan is unsuccessful A screening Aspartate Aminotransferase to
Platelet Ratio Index (APRI) = 2 and no clinical or laboratory evidence of cirrhosis;

- HCV treatment naive or pegylated or standard interferon and ribavirin experienced;

- Willing and able to provide written informed consent

Subjects must have the following laboratory parameters at screening:

- ALT = 10 times the upper limit of normal (ULN);

- AST = 10 times ULN

- Haemoglobin = 12g/dL for males; = 11g/dL for female subjects;

- Platelet count = laboratory lower limit of normal;

- INR = laboratory upper limit of normal, unless stable on an anticoagulant regimen
affecting INR;

- Albumin = laboratory lower limit of normal;

- Direct bilirubin = laboratory upper limit of normal;

- Creatinine clearance (Clcr) = 60mL/min as calculated by Cockcroft-Gault equation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known cirrhosis defined as:

Liver biopsy within 24 months prior to screening demonstrating cirrhosis (e.g. a Metavir
score > 3 or an Ishak score > 4); or A FibroScan result of >12.5 kPa; or Prior clinical
evidence of cirrhosis or portal hypertension (i.e. ascites, varices).

- Prior exposure to HCV DAA protease inhibitors

- Currently receiving HCV treatment;

- Testing positive for HIV;

- Testing positive for HBsAg;

- HCC;

- Pregnancy or breastfeeding at screening or baseline;

- Evidence of any condition, therapy, laboratory abnormality or other circumstance
(current or prior) that may confound the study's results, or interfere with
participation for the full duration of the study, such that it is not in the best
interest of the participant;

- Use of concomitant medications that are contraindicated with Viekira Pak within 28
days of the baseline/day 1 visit, that are unable to be ceased for the duration of
treatment.

Additional exclusion criteria for participants receiving ribavirin:

- increased baseline risk for anaemia (i.e. history of thalassaemia, spherocytosis,
history of GI bleeding) or;

- patients for whom anaemia would be medically problematic or;

- documented of presumed coronary artery disease or cerebrovascular disease, if in the
judgement of the investigator, an acute decrease in haemoglobin by up to 4 g/dL (as
may be seen with ribavirin) would not be well tolerated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/05/2018
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [2] 0 0
Burnet Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment postcode(s) [2] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Prime Study is a randomised trial investigating models of care for hepatitis C in the era
of direct acting antiviral (DAA) therapy. The study aims to compare outcomes of hepatitis C
care and DAA treatment provided in a primary health care service with a tertiary hospital.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02555475
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT02555475