Liver CirrhosisPhase 3AspiRe HCCNCT07529262
Can Aspirin Reduce the Risk of HCC in Cirrhosis: The AspiRe HCC Trial
A Phase 3 study testing Low-dose aspirin in people with Liver Cirrhosis, run by Curtin University.
Trial summary
This clinical trial is testing whether taking a low dose aspirin tablet (100 mg) once a day can help prevent liver cancer (hepatocellular carcinoma, HCC) in people who have cirrhosis, which is severe scarring of the liver. People with cirrhosis have a higher risk of developing HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Low-dose aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 890 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent to participate in the trial according to ICH GCP (R3) and national/local regulations.
- Diagnosed with liver cirrhosis for at least 6 months
- Has a current Child-Pugh score ≤6 (Child A - clinically and biochemically compensated cirrhosis)
- Has been participating in ultrasound or non-ultrasound (computed tomography (CT) or magnetic resonance imaging (MRI)) based surveillance for at least 6 months prior to entry.
- Has not had any focal lesions, other than haemangiomas, detected during the past 6 months.
Who cannot join
- Any of the following:
- autoimmune liver disease.
- primary biliary cholangitis.
- primary sclerosing cholangitis.
- prior HCC
- alcohol consumption >3 standard drinks per day in men and 2 standard drinks per day in women.
Show all 18Show fewer
- currently taking a nonsteroidal anti-inflammatory drug, anticoagulant drugs, non-vitamin K anticoagulant frugs, or other antiplatelet drugs, including aspirin, within the last 6 months.
- a known bleeding disorder
- a platelet count <50 x 109/L.
- known history or endoscopic evidence of high risk oesophageal (grade 2 or higher) or gastric varices or, a history of bleeding varices.
- chronic iron deficiency anaemia.
- a prior history of liver decompensation or liver transplantation.
- known peptic ulcer disease.
- chronic kidney disease with eGFR <50ml/min; a contraindication to aspirin.
- Any participant considered by the PI to be deemed unlikely to complete the study due to other comorbid conditions or poor compliance will also be excluded.
- Pregnancy:
- Whilst low dose aspirin is considered safe in pregnancy, male and female participants of child-bearing potential are recommended use effective contraception during this trial.
- Any female participants who fall pregnant during the trial will be withdrawn if their treating obstetric doctor advises that you should do so.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Can Aspirin Reduce the Risk of Hepatocellular Carcinoma (HCC) in Participants With Cirrhosis: a Multicentre, Placebo-controlled Clinical Trial - The AspiRe HCC Trial
This clinical trial is testing whether taking a low dose aspirin tablet (100 mg) once a day can help prevent liver cancer (hepatocellular carcinoma, HCC) in people who have cirrhosis, which is severe scarring of the liver. People with cirrhosis have a higher risk of developing HCC. Currently, there is no approved treatment that prevents liver cancer in this group.
Research from around the world suggests that low dose aspirin might reduce the risk of liver cancer by up to half and is safe for people with cirrhosis. However, it is not yet approved for this purpose in Australia. A trial is needed to find out if aspirin really can prevent liver cancer in people with cirrhosis and is safe for these people to use.
Read more
890 people from up to 7 hospitals across Australia will take part.
Participants will take medication daily for 4 years. They will be randomly allocated to either aspirin or a placebo (dummy pill).
Participants will continue to have their regular 6 monthly clinic visit with liver ultrasounds and blood tests as part of their normal care.
If at any time liver cancer is found, they will stop the trial.
Participants will also complete some extra tasks:
- Record missed doses or other medications in a small diary.
- Fill in two short quality of life surveys each year.
- Return their medication and diary at their regular 6 monthly appointments.
- In Western Australia only: they will be invited to give optional blood samples for future research.
Read the detailed description
The AspiRe HCC trial is a large clinical study designed to find out whether daily low-dose aspirin (100 mg) can help prevent hepatocellular carcinoma (HCC)-the most common form of liver cancer-in people who already have liver cirrhosis.
HCC rates are rising in Australia and worldwide and more than 90% of HCC cases occur in people with cirrhosis. Less than 20% of people with cirrhosis have HCC diagnosed early enough for it to be curable. Diagnosis of HCC at an early stage increases the chances of being able to cure it or stop it from growing or spreading. Previous research suggests aspirin may reduce the risk of developing HCC by 50-70%, with stronger benefits in people who already have cirrhosis.
Ideally, we need to prevent HCC developing in the first place. However, there is no current treatment to preventing HCC in people with cirrhosis.
Experimental studies in animals and humans have shown that that aspirin treatment is safe and may prevent HCC, reducing the risk by at least 50% in people with cirrhosis. Studies from around the world have shown that people taking low-dose aspirin (100 mg daily or sometimes called "mini-aspirin") for other reasons (such as for heart disease or stroke prevention) have a much lower risk of developing HCC. Importantly, people who use aspirin in these settings do not seem to have any increase in the rates of side effects compared to people who do not take aspirin.
If proven effective, aspirin could become a simple and affordable preventative treatment, potentially saving hundreds of lives each year and reducing healthcare costs.
People with lived experience of cirrhosis and liver cancer have been involved in designing and reviewing the study to ensure it is relevant, ethical and meaningful. They will continue contributing as members of the Trial Steering Committee.
This trial is a multi-centre, prospective, pragmatic 4-year RCT of aspirin versus placebo therapy in 890 stable, well-compensated cirrhotic participants attending hospital outpatient clinics and otherwise receiving standard of care treatment at up to seven sites across Australian.
Participants will be randomly assigned in a 1:1 ratio to either a 100 mg tablet of enteric-coated aspirin daily or placebo therapy, according to a block-randomisation procedure and their date of enrolment in the study.
Participants will continue their usual care. At each 6 monthly standard of care visit, during their 4 years on study, the site team will enter data into a REDCap database:
- Routine blood test results
- Routine liver imaging for monitoring of occurrence of HCC (ultrasound, CT, or MRI)
- Routine liver elastography once a year
- Any hospital admissions or new symptoms
- QOL information via two surveys' (Ed-5q-5L and CLDQ)
Western Australian participants may consent to optional additional blood sample collection, at baseline and end of trial, for a biological specimen repository to support future research.
All participants will be invited to consent to provision of their MBS/PBS data during the trial, to analyse the cost of treatment and life years saved.
Any participant who is diagnosed with HCC during their time on trial has reached the primary endpoint and will cease their participation
- Conditions
- Liver Cirrhosis
- Being tested
- Low-dose aspirin, Placebo Comparator
- Keywords
- Hepatic, Cancer, Carcinoma, Hepatocellular, Liver, Cirrhosis
- Medical subject headings
- Liver Cirrhosis, Neoplasms, Carcinoma, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose aspirinDrug
Also called acetylsalicylic acid
a capsule containing100mg Low Dose Aspirin
Placebo ComparatorDrug
an identical capsule containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| Low dose Aspirin | Active comparator | Low dose aspirin, 100mg, once daily for 4 years or until diagnosis of HCC Receives: Drug: Low-dose aspirin |
| Placebo | Placebo comparator | Placebo, once daily for 4 years or until diagnosis of HCC Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of HCC in participants receiving aspirin or placebo
Incidence of HCC, which is defined as the presence or absence of HCC at study completion in participants receiving aspirin compared to placebo
Measured: Randomisation to End of study - 4 years treatment
Secondary outcomes (6)
Number of Adverse Events
Total number and type of adverse events, reported using CTCAE terminology and relatedness, in participants receiving aspirin compared to placebo
Measured: Randomisation to End of study - 4 years treatment
Treatment Compliance
Adherence to treatment assessed by drug accountability and patient diary for participants receiving aspirin compared to placebo
Measured: Randomisation to End of study - 4 years treatment
Hospital admissions for clinical complications of cirrhosis
Total number of hospital admissions for clinical complications of cirrhosis occurring in participants receiving aspirin compared to placebo
Measured: Randomisation to End of study - 4 years treatment
Quality of Life (QOL) - EQ-5D-5L
The EQ-5D-5L is a short, easy-to-use, self-reported measure of health status. It includes two components: a health questionnaire and a visual analogue scale (EQ-VAS).
The EQ-VAS asks respondents to rate their overall current health on a vertical scale ranging from "the best health you can imagine" to "the worst health you can imagine", providing a quantitative measure of perceived health and allowing changes over time to be monitored.
The questionnaire assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability.
Responses are combined into a single utility score representing overall health status. Higher scores indicate worse quality of life. This utility score will be used to calculate Quality-Adjusted Life Years (QALYs) and results for participants treated with aspirin compared to placebo.
Measured: Randomisation to End of study - 4 years treatment
Quality of Life (QOL) - CLDQ
The Chronic Liver Disease Questionnaire (CLDQ) is a validated, self-reported measure of health-related quality of life in people with chronic liver disease. It comprises 29 items across six domains: abdominal symptoms, fatigue, emotional health, activity/energy, systemic symptoms, and worry. Each item is rated on a 7-point Likert scale ranging from "all of the time" to "none of the time", with higher scores indicating better quality of life. The higher the number, the better the quality of life.
Results of participants treated with aspirin will be compared to those treated with placebo.
Measured: Randomisation to End of study - 4 years treatment
Resource Utilization and Cost-effectiveness of Treatment
Cost utility analysis of aspirin compared to placebo in preventing HCC in people with cirrhosis will be performed.
The following data sources will be used to calculate this outcome measure. National Hospital Cost Data Collection (NHCDC) and Medical Cost Finder, Australian Refined Diagnosis Related Groups (AR-DRGs), Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS).
AR-DRGs are large data cubes that represents the costing for a class of patients with similar clinical conditions requiring similar hospital service MBS/PBS data is Australian Government collected data recording prescriptions and health service use for the duration of participants time in the study.
Health utilities scores will come from the CLDQ and EQ-5D-5L.
Measured: Randomisation to End of study - 4 years treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre, prospective, randomised clinical trial (RCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John K Olynyk, BMedSc MBBS FRACP MD FAASLD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529262
- Sponsor's protocol ID
- AspiRe HCC (RES-69007)
- Other IDs
- 2041836, U1111-1335-6237
- Acronym
- AspiRe HCC
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Aspirin Reduce the Risk of Hepatocellular Carcinoma (HCC) in Participants With Cirrhosis: a Multicentre, Placebo-controlled Clinical Trial - The AspiRe HCC Trial
- ClinicalTrials.gov ID
- NCT07529262
- Acronym / sponsor ID
- AspiRe HCC / AspiRe HCC (RES-69007)
- Conditions
- Liver Cirrhosis
- Keywords
- Hepatic, Cancer, Carcinoma, Hepatocellular, Liver, Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 890 participants (estimated)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 14 Apr 2026 (actual)
- 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 clinical trial is testing whether taking a low dose aspirin tablet (100 mg) once a day can help prevent liver cancer (hepatocellular carcinoma, HCC) in people who have cirrhosis, which is severe scarring of the liver. People with cirrhosis have a higher risk of developing HCC. Currently, there is no approved treatment that prevents liver cancer in this group.
Research from around the world suggests that low dose aspirin might reduce the risk of liver cancer by up to half and is safe for people with cirrhosis. However, it is not yet approved for this purpose in Australia. A trial is needed to find out if aspirin really can prevent liver cancer in people with cirrhosis and is safe for these people to use.
890 people from up to 7 hospitals across Australia will take part.
Participants will take medication daily for 4 years. They will be randomly allocated to either aspirin or a placebo (dummy pill).
Participants will continue to have their regular 6 monthly clinic visit with liver ultrasounds and blood tests as part of their normal care.
If at any time liver cancer is found, they will stop the trial.
Participants will also complete some extra tasks:
- Record missed doses or other medications in a small diary.
- Fill in two short quality of life surveys each year.
- Return their medication and diary at their regular 6 monthly appointments.
- In Western Australia only: they will be invited to give optional blood samples for future research.
Detailed description
The AspiRe HCC trial is a large clinical study designed to find out whether daily low-dose aspirin (100 mg) can help prevent hepatocellular carcinoma (HCC)-the most common form of liver cancer-in people who already have liver cirrhosis.
HCC rates are rising in Australia and worldwide and more than 90% of HCC cases occur in people with cirrhosis. Less than 20% of people with cirrhosis have HCC diagnosed early enough for it to be curable. Diagnosis of HCC at an early stage increases the chances of being able to cure it or stop it from growing or spreading. Previous research suggests aspirin may reduce the risk of developing HCC by 50-70%, with stronger benefits in people who already have cirrhosis.
Ideally, we need to prevent HCC developing in the first place. However, there is no current treatment to preventing HCC in people with cirrhosis.
Experimental studies in animals and humans have shown that that aspirin treatment is safe and may prevent HCC, reducing the risk by at least 50% in people with cirrhosis. Studies from around the world have shown that people taking low-dose aspirin (100 mg daily or sometimes called "mini-aspirin") for other reasons (such as for heart disease or stroke prevention) have a much lower risk of developing HCC. Importantly, people who use aspirin in these settings do not seem to have any increase in the rates of side effects compared to people who do not take aspirin.
If proven effective, aspirin could become a simple and affordable preventative treatment, potentially saving hundreds of lives each year and reducing healthcare costs.
People with lived experience of cirrhosis and liver cancer have been involved in designing and reviewing the study to ensure it is relevant, ethical and meaningful. They will continue contributing as members of the Trial Steering Committee.
This trial is a multi-centre, prospective, pragmatic 4-year RCT of aspirin versus placebo therapy in 890 stable, well-compensated cirrhotic participants attending hospital outpatient clinics and otherwise receiving standard of care treatment at up to seven sites across Australian.
Participants will be randomly assigned in a 1:1 ratio to either a 100 mg tablet of enteric-coated aspirin daily or placebo therapy, according to a block-randomisation procedure and their date of enrolment in the study.
Participants will continue their usual care. At each 6 monthly standard of care visit, during their 4 years on study, the site team will enter data into a REDCap database:
- Routine blood test results
- Routine liver imaging for monitoring of occurrence of HCC (ultrasound, CT, or MRI)
- Routine liver elastography once a year
- Any hospital admissions or new symptoms
- QOL information via two surveys' (Ed-5q-5L and CLDQ)
Western Australian participants may consent to optional additional blood sample collection, at baseline and end of trial, for a biological specimen repository to support future research.
All participants will be invited to consent to provision of their MBS/PBS data during the trial, to analyse the cost of treatment and life years saved.
Any participant who is diagnosed with HCC during their time on trial has reached the primary endpoint and will cease their participation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicentre, prospective, randomised clinical trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Low dose Aspirin | Active comparator | Drug: Low-dose aspirinLow dose aspirin, 100mg, once daily for 4 years or until diagnosis of HCC |
| Placebo | Placebo comparator | Drug: Placebo ComparatorPlacebo, once daily for 4 years or until diagnosis of HCC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent to participate in the trial according to ICH GCP (R3) and national/local regulations.
- Diagnosed with liver cirrhosis for at least 6 months
- Has a current Child-Pugh score ≤6 (Child A - clinically and biochemically compensated cirrhosis)
- Has been participating in ultrasound or non-ultrasound (computed tomography (CT) or magnetic resonance imaging (MRI)) based surveillance for at least 6 months prior to entry.
- Has not had any focal lesions, other than haemangiomas, detected during the past 6 months.
Key exclusion criteria (18 listed)
- Any of the following:
- Whilst low dose aspirin is considered safe in pregnancy, male and female participants of child-bearing potential are recommended use effective contraception during this trial.
- Any female participants who fall pregnant during the trial will be withdrawn if their treating obstetric doctor advises that you should do so.
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 |
|---|---|---|
| Low-dose aspirinAlso: acetylsalicylic acida capsule containing100mg Low Dose Aspirin | Drug | Low dose Aspirin |
| Placebo Comparatoran identical capsule containing no active drug | Drug | Placebo |
Primary outcome
Overall incidence of HCC in participants receiving aspirin or placebo
Time frame: Randomisation to End of study - 4 years treatment
Incidence of HCC, which is defined as the presence or absence of HCC at study completion in participants receiving aspirin compared to placebo
6 secondary outcomes
Number of Adverse Events
Time frame: Randomisation to End of study - 4 years treatment
Treatment Compliance
Time frame: Randomisation to End of study - 4 years treatment
Hospital admissions for clinical complications of cirrhosis
Time frame: Randomisation to End of study - 4 years treatment
Quality of Life (QOL) - EQ-5D-5L
Time frame: Randomisation to End of study - 4 years treatment
Quality of Life (QOL) - CLDQ
Time frame: Randomisation to End of study - 4 years treatment
Resource Utilization and Cost-effectiveness of Treatment
Time frame: Randomisation to End of study - 4 years treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
John K Olynyk, BMedSc MBBS FRACP MD FAASLD principal investigator
Curtin University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-dose aspirin in people with Liver Cirrhosis, run by Curtin University.
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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Galettis, PhD (+61 (08) 9266 9509, rachel.galettis@curtin.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of HCC in participants receiving aspirin or placebo (time frame: Randomisation to End of study - 4 years treatment). 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 14 Apr 2026.