Can Aspirin Reduce the Risk of HCC in Cirrhosis: The AspiRe HCC Trial
ConditionLiver Cirrhosis
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low-dose aspirin
Druga capsule containing100mg Low Dose Aspirin
Placebo Comparator
Drugan identical capsule containing no active drug
Treatment groups
890 Participants
are divided into 2 treatment groupsGroup A: Low dose AspirinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: