Can Aspirin Reduce the Risk of HCC in Cirrhosis: The AspiRe HCC Trial

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCurtin University

About this 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.

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

autoimmune liver disease.

primary biliary cholangitis.

primary sclerosing cholangitis.

prior HCC

Trial design

Treatments tested in this trial

  • Low-dose aspirin
  • Placebo Comparator

Treatment groups

890 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators