Hepatitis CNCT02555475
The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital
A study testing community based hepatitis C care and treatment in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- community based hepatitis C care and treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Mar 2016to 22 May 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
New Zealand6 sites
Calder Centre Auckland
Auckland, 1010
Auckland Central liver Clinic
Auckland, 1023
Community Alcohol and Drug Services
Auckland, 1023
Hospital Liver Clinic
Greenlane, Auckland, 1051
Auckland Opioid Treatment Service (AOTS)
Point Chevalier, Auckland, 1025
Hepatitis C Community Clinic
Sydenham, Christchurch, 8011
Australia2 sites
St Vincents Hospital Melbourne
Melbourne, Victoria, 3065
Burnet Institute
Melbourne, Victoria, 3181
About this study
Official title: The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial
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.
Read the detailed description
This open label randomised trial will investigate the efficacy of treating people with G1 HCV with DAA in primary healthcare services compared with tertiary hospital clinics. Three hundred and eighty G1 HCV infected patients attending study primary healthcare centres will be invited to participate in the study.
At the primary healthcare centre participants will be randomly allocated to two groups:
Group 1: (n=190) Following their initial screen, these participants will be referred to a tertiary hospital for transient elastography and DAA treatment (traditional model of care)
Group 2: (n=190) Following their initial screen, these participants will be offered transient elastography and DAA treatment delivered at the primary healthcare service only.
Treatment will consist of fixed dose combination paritaprevir, ombitasvir and ritonavir packaged together with dasabuvir, known as Viekira Pak, +/- weight based ribavirin. As cirrhotic patients will be excluded from the study, the duration of treatment is 12 weeks.
- Conditions
- Hepatitis C
- Being tested
- community based hepatitis C care and treatment
- Keywords
- Hepatitis C, primary care
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community based hepatitis C care and treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1, tertiary hospital based care | No intervention | 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). |
| Group 2, community based care | Experimental | 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. Receives: Other: community based hepatitis C care and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sustained virology response (SVR) rates at week 12 post treatment.
Secondary outcomes (5)
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.
Measured: Treatment uptake within 8 weeks of randomisation
To measure the proportion of people with G1 HCV who have an SVR12 at a PHCS compared a tertiary hospital.
Measured: SVR rate at week 12 post treatment
To measure the reduction in HCV viraemia (community viral load) among participants considering retention through the cascade of care and SVR12.
Measured: up to 24 weeks post treatment
To measure the cost effectiveness of managing and treating people in a primary health service compared to a tertiary hospital.
Measured: up to 24 weeks post treatment
To define the cascade of care for patients referred to a community hepatitis nurse for assessment of HCV.
Measured: up to 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion22 Dec 2017
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- St Vincent's Hospital Melbourne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555475
- Sponsor's protocol ID
- HREC/15/SVHM/41
- Status last verified
- Jul 2017
- First submitted
- 17 Sep 2015
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N, Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME. Outcomes of Treatment for Hepatitis C in Primary Care, Compared to Hospital-based Care: A Randomized, Controlled Trial in People Who Inject Drugs. Clin Infect Dis. 2020 Apr 15;70(9):1900-1906. doi: 10.1093/cid/ciz546.
PubMed 31233117Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N, Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME. Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial. Trials. 2018 Jul 16;19(1):383. doi: 10.1186/s13063-018-2768-3.
PubMed 30012192
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial
- ClinicalTrials.gov ID
- NCT02555475
- Acronym / sponsor ID
- HREC/15/SVHM/41
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- St Vincent's Hospital Melbourne
- Study start
- Mar 2016 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 21 Sep 2015 (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.
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.
Detailed description
This open label randomised trial will investigate the efficacy of treating people with G1 HCV with DAA in primary healthcare services compared with tertiary hospital clinics. Three hundred and eighty G1 HCV infected patients attending study primary healthcare centres will be invited to participate in the study.
At the primary healthcare centre participants will be randomly allocated to two groups:
Group 1: (n=190) Following their initial screen, these participants will be referred to a tertiary hospital for transient elastography and DAA treatment (traditional model of care)
Group 2: (n=190) Following their initial screen, these participants will be offered transient elastography and DAA treatment delivered at the primary healthcare service only.
Treatment will consist of fixed dose combination paritaprevir, ombitasvir and ritonavir packaged together with dasabuvir, known as Viekira Pak, +/- weight based ribavirin. As cirrhotic patients will be excluded from the study, the duration of treatment is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, tertiary hospital based care | No intervention | –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). |
| Group 2, community based care | Experimental | Other: community based hepatitis C care and treatmentGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community based hepatitis C care and treatment | Other | Group 2, community based care |
Primary outcome
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.
Time frame: Sustained virology response (SVR) rates at week 12 post treatment.
5 secondary outcomes
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.
Time frame: Treatment uptake within 8 weeks of randomisation
To measure the proportion of people with G1 HCV who have an SVR12 at a PHCS compared a tertiary hospital.
Time frame: SVR rate at week 12 post treatment
To measure the reduction in HCV viraemia (community viral load) among participants considering retention through the cascade of care and SVR12.
Time frame: up to 24 weeks post treatment
To measure the cost effectiveness of managing and treating people in a primary health service compared to a tertiary hospital.
Time frame: up to 24 weeks post treatment
To define the cascade of care for patients referred to a community hepatitis nurse for assessment of HCV.
Time frame: up to 12 weeks post treatment
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 24 May 2018.
- Derived from this study: PubMed 31233117Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N, Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME. Outcomes of Treatment for Hepatitis C in Primary Care, Compared to Hospital-based Care: A Randomized, Controlled Trial in People Who Inject Drugs. Clin Infect Dis. 2020 Apr 15;70(9):1900-1906. doi: 10.1093/cid/ciz546.
- Derived from this study: PubMed 30012192Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N, Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME. Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial. Trials. 2018 Jul 16;19(1):383. doi: 10.1186/s13063-018-2768-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community based hepatitis C care and treatment in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 8 sites in 2 countries.
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 16 inclusion and 14 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 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in New Zealand, 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?
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. (time frame: Sustained virology response (SVR) rates at week 12 post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555475, which also lists 2 linked publications.
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 24 May 2018.