A Phase 3 interventional study of Low-dose aspirin and Placebo Comparator in Liver Cirrhosis, sponsored by Curtin University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Curtin University · Phase 3, Interventional, and Prevention
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:
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:
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
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 890 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Curtin University is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following:
Pregnancy:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low dose aspirin, 100mg, once daily for 4 years or until diagnosis of HCC
Drug: Low-dose aspirin
Placebo, once daily for 4 years or until diagnosis of HCC
Drug: Placebo Comparator
a capsule containing100mg Low Dose Aspirin
Also known as: acetylsalicylic acid
an identical capsule containing no active drug
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
Time frame: Randomisation to End of study - 4 years treatment
Number of Adverse Events
Total number and type of adverse events, reported using CTCAE terminology and relatedness, in participants receiving aspirin compared to placebo
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Randomisation to End of study - 4 years treatment
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
Curtin University