Liver CirrhosisPhase 3APEACHNCT07726693
Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial
A Phase 3 study testing Apixaban 2.5 mg twice daily in people with Liver Cirrhosis, run by University College, London.
Trial summary
Liver disease is the only common cause of death that is increasing in numbers. Once people develop severe scarring (cirrhosis), there are no medications proven to help them live longer, healthier lives. Apixaban is already commonly used to prevent or treat blood clots and is known to be safe for those with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Apixaban 2.5 mg twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,142 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Mar 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis secondary to alcohol, with or without associated metabolic risk factors, i.e. Alcohol related liver disease (ARLD) or metabolic dysfunction-associated steatotic liver disease, where there has been a significant history of alcohol consumption (MetALD)
- Cirrhosis will be based on histology, or clear radiological evidence, e.g. nodular or heterogeneous liver or non-invasive testing (e.g. Fibroscan®, or Enhanced Liver Fibrosis (ELF) test
- Childs A Cirrhosis (Participants with a previous episode of decompensated cirrhosis who have now recompensated can be included)
- Participants with no hepatic encephalopathy or low-grade hepatic encephalopathy (Grade 0 or 1) taking lactulose and/or rifaximin
- Aged ≥18 years
- Clinical evidence of portal hypertension, defined as any 1 of:
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- Evidence of abdominal collateral circulation, recanalised umbilical vein or varices on imaging
- Asymptomatic ascites (trace only) seen around the liver on imaging in patients who are not taking diuretics
- Liver stiffness measurement >20kPa on FibroScan®/ Vibration- Controlled Transient Elastography (VCTE) (where BMI <35)
- Presence of Gastro-oesophageal varices at endoscopy
- Hepatic venous pressure gradient ≥ 10mmHg
- Or Platelet count < 150,000 μL AND any 1 of:
- Spleen size >13 cm in length
- Liver stiffness measurement >20kPa on FibroScan®/VCTE (where BMI >35)
- Presence of portal hypertensive gastropathy at endoscopy
Who cannot join
- Evidence of decompensation (e.g. ascites requiring treatment other than a thin rim around liver on imaging, as above) (Evidence of decompensation as follows: Grade 2 or 3 Ascites, Grade 2 - 4 Hepatic Encephalopathy, Variceal Haemorrhage)
- Causes for cirrhosis other than alcohol, including those with MASLD who have never drunk alcohol above government recommended levels (14 units/week)
- Pre-existing splanchnic vein thrombosis (portal, splenic, mesenteric, and hepatic veins)
- Use of (and need for) anticoagulation or dual antiplatelet therapy or clopidogrel
- Platelets <50x109/L at screening
- Moderate-severe renal impairment defined as eGFR <30ml/min at screening
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- Recent variceal bleed or untreated large varices
- Malignancy in last 2 years if unlikely to survive trial because of comorbidity in the location PI's opinion
- Hepatocellular carcinoma
- Severe cardiac failure1 or Chronic Obstructive Pulmonary Disease (COPD)
- Pregnancy
- INR >1.7 (After vitamin K correction) at screening
- Previous hypersensitivity reaction to Apixaban
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lee Webber contact
About this study
Official title: Apixaban to Prevent dEcompensation of eArly Liver CirrHosis Trial
Liver disease is the only common cause of death that is increasing in numbers. Once people develop severe scarring (cirrhosis), there are no medications proven to help them live longer, healthier lives. Apixaban is already commonly used to prevent or treat blood clots and is known to be safe for those with cirrhosis.
In the early stages of cirrhosis, most people have no symptoms and lead normal lives; this is called "compensated" cirrhosis. However, when the liver stops working properly, they develop "decompensated" cirrhosis, which causes yellow skin, confusion, vomiting of blood and painful fluid build-up. This is serious, and people are extremely unwell with a poor quality of life, often need to go to the hospital and on average only live for 2 more years.
Read more
The APEACH trial will investigate whether giving compensated cirrhosis patients Apixaban will help stop them from developing decompensated cirrhosis and stay in good health for longer.
Previous research studies suggest that taking blood-thinning drugs is safe and helpful for cirrhosis. However, these did not have enough participants to be confident enough in the results to recommend use in everyday clinical care.
The APEACH trial will include enough participants to make it clear whether Apixaban is helpful or not.
- Conditions
- Liver Cirrhosis
- Being tested
- Apixaban 2.5 mg twice daily, Placebo
- Keywords
- Liver Cirrhosis, Alcohol Related Liver Disease (ARLD), Metabolic dysfunction-associated steatotic liver disease, Apixaban, MetALD
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 mg twice dailyDrug
Participants randomised to this arm will receive Apixaban 2.5mg twice daily
PlaceboDrug
Placebo will be given as oral tablet and taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| Participants randomised to receive Apixaban 2.5mg oral tablet twice daily | Placebo comparator | Participants randomised to receive a matching placebo Receives: Drug: Placebo |
| Participants randomised to receive Apixaban 2.5mg twice daily | Experimental | Not described Receives: Drug: Apixaban 2.5 mg twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomisation to first decompensation event, assessed up to 49 months
First decompensation event is defined as at least one of the following:
Grade 2 or 3 ascites according to the International Club of Ascites (ICA), or spontaneous bacterial peritonitis; Grade 2-4 hepatic encephalopathy; variceal haemorrhage (gastrointestinal bleeding secondary to rupture of varices); and liver-related death measured using METHOD at 6-monthly trial follow-up visits and throughout the trial, when location study teams become aware of these events, as decompensation normally involves hospitalisation
Measured: Time from randomisation to first decompensation event, assessed up to 49 months
Secondary outcomes (8)
Time from randomisation to first decompensation event, assessed up to 49 months
Time to event for individual decompensation events measured at 6-monthly follow-up visits, assessed up to 49 months
Measured: Time from randomisation to first decompensation event, assessed up to 49 months
Time to development of grade 1 (small volume) ascites
Small volume ascites
Measured: Time from randomisation assessed up to 49 months
Assessment of safety of anticoagulation in Childs A cirrhosis patients
Assessment of safety of anticoagulation in Childs A cirrhosis patients, including incidence of clinically relevant combined major bleeding and non-major bleeding during trial treatment period
Measured: Time from randomisation assessed up to 49 months
Time to all-cause mortality
Measured: Time from randomisation assessed up to 49 months
Time to portal vein thrombosis or other thromboembolic events
Measured: Time from randomisation assessed up to 49 months
Incidence of cardiac events
Measured: Time from randomisation assessed up to 49 months
Alcohol use
Alcohol use will be determined by patient reporting on AUDIT-C questionnaire
Measured: Time from baseline assessed up to 49 months
Health-related quality of life assessed using EQ-5D-5L questionnaire
Measured: Time from randomisation assessed up to 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion31 Oct 2030 (estimated)
- Study completion30 Mar 2031 (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.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Apixaban 2.5mg twice daily to prevent liver decompensation in patients with liver cirrhosis
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust, NHS Greater Glasgow and Clyde, University Hospital of Wales, University of Nottingham, Liverpool University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, King's College Hospital NHS Trust, King's College London, Hull University Teaching Hospitals NHS Trust, Imperial College London, The Leeds Teaching Hospitals NHS Trust, The Royal London Hospital, UK, BRITISH LIVER TRUST
- Responsible party
- Sponsor
- Investigators
- Alastair O'Brien, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726693
- Sponsor's protocol ID
- CCTU 2023-474
- Other IDs
- 1013519
- Acronym
- APEACH
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban to Prevent dEcompensation of eArly Liver CirrHosis Trial
- ClinicalTrials.gov ID
- NCT07726693
- Acronym / sponsor ID
- APEACH / CCTU 2023-474
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Alcohol Related Liver Disease (ARLD), Metabolic dysfunction-associated steatotic liver disease, Apixaban, MetALD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,142 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust, NHS Greater Glasgow and Clyde, University Hospital of Wales, University of Nottingham, Liverpool University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, King's College Hospital NHS Trust, King's College London, Hull University Teaching Hospitals NHS Trust, Imperial College London, The Leeds Teaching Hospitals NHS Trust, The Royal London Hospital, UK, BRITISH LIVER TRUST
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 30 Mar 2031 (estimated)
- First posted
- 24 Jul 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.
Liver disease is the only common cause of death that is increasing in numbers. Once people develop severe scarring (cirrhosis), there are no medications proven to help them live longer, healthier lives. Apixaban is already commonly used to prevent or treat blood clots and is known to be safe for those with cirrhosis.
In the early stages of cirrhosis, most people have no symptoms and lead normal lives; this is called "compensated" cirrhosis. However, when the liver stops working properly, they develop "decompensated" cirrhosis, which causes yellow skin, confusion, vomiting of blood and painful fluid build-up. This is serious, and people are extremely unwell with a poor quality of life, often need to go to the hospital and on average only live for 2 more years.
The APEACH trial will investigate whether giving compensated cirrhosis patients Apixaban will help stop them from developing decompensated cirrhosis and stay in good health for longer.
Previous research studies suggest that taking blood-thinning drugs is safe and helpful for cirrhosis. However, these did not have enough participants to be confident enough in the results to recommend use in everyday clinical care.
The APEACH trial will include enough participants to make it clear whether Apixaban is helpful or not.
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 randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Apixaban 2.5mg twice daily to prevent liver decompensation in patients with liver cirrhosis
| Arm | Type | Receives |
|---|---|---|
| Participants randomised to receive Apixaban 2.5mg oral tablet twice daily | Placebo comparator | Drug: PlaceboParticipants randomised to receive a matching placebo |
| Participants randomised to receive Apixaban 2.5mg twice daily | Experimental | Drug: Apixaban 2.5 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Liver cirrhosis secondary to alcohol, with or without associated metabolic risk factors, i.e. Alcohol related liver disease (ARLD) or metabolic dysfunction-associated steatotic liver disease, where there has been a significant history of alcohol consumption (MetALD)
- Cirrhosis will be based on histology, or clear radiological evidence, e.g. nodular or heterogeneous liver or non-invasive testing (e.g. Fibroscan®, or Enhanced Liver Fibrosis (ELF) test
- Childs A Cirrhosis (Participants with a previous episode of decompensated cirrhosis who have now recompensated can be included)
- Participants with no hepatic encephalopathy or low-grade hepatic encephalopathy (Grade 0 or 1) taking lactulose and/or rifaximin
- Aged ≥18 years
Key exclusion criteria (13 listed)
- Evidence of decompensation (e.g. ascites requiring treatment other than a thin rim around liver on imaging, as above) (Evidence of decompensation as follows: Grade 2 or 3 Ascites, Grade 2 - 4 Hepatic Encephalopathy, Variceal Haemorrhage)
- Causes for cirrhosis other than alcohol, including those with MASLD who have never drunk alcohol above government recommended levels (14 units/week)
- Pre-existing splanchnic vein thrombosis (portal, splenic, mesenteric, and hepatic veins)
- Use of (and need for) anticoagulation or dual antiplatelet therapy or clopidogrel
- Platelets <50x109/L at screening
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 |
|---|---|---|
| Apixaban 2.5 mg twice dailyParticipants randomised to this arm will receive Apixaban 2.5mg twice daily | Drug | Participants randomised to receive Apixaban 2.5mg twice daily |
| PlaceboPlacebo will be given as oral tablet and taken twice daily | Drug | Participants randomised to receive Apixaban 2.5mg oral tablet twice daily |
Primary outcome
Time from randomisation to first decompensation event, assessed up to 49 months
Time frame: Time from randomisation to first decompensation event, assessed up to 49 months
First decompensation event is defined as at least one of the following: Grade 2 or 3 ascites according to the International Club of Ascites (ICA), or spontaneous bacterial peritonitis; Grade 2-4 hepatic encephalopathy; variceal haemorrhage (gastrointestinal bleeding secondary to rupture of varices); and liver-related death measured using METHOD at 6-monthly trial follow-up visits and throughout the trial, when location study teams become aware of these events, as decompensation normally involves hospitalisation
8 secondary outcomes
Time from randomisation to first decompensation event, assessed up to 49 months
Time frame: Time from randomisation to first decompensation event, assessed up to 49 months
Time to development of grade 1 (small volume) ascites
Time frame: Time from randomisation assessed up to 49 months
Assessment of safety of anticoagulation in Childs A cirrhosis patients
Time frame: Time from randomisation assessed up to 49 months
Time to all-cause mortality
Time frame: Time from randomisation assessed up to 49 months
Time to portal vein thrombosis or other thromboembolic events
Time frame: Time from randomisation assessed up to 49 months
Incidence of cardiac events
Time frame: Time from randomisation assessed up to 49 months
Alcohol use
Time frame: Time from baseline assessed up to 49 months
Health-related quality of life assessed using EQ-5D-5L questionnaire
Time frame: Time from randomisation assessed up to 49 months
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 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lee Webber contact
Alastair O'Brien principal investigator
Queen Mary University of London
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban 2.5 mg twice daily in people with Liver Cirrhosis, run by University College, London.
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 15 inclusion and 13 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 24 Jul 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 APEACH Trial Team (0207 670 4813, cctu.apeach@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomisation to first decompensation event, assessed up to 49 months (time frame: Time from randomisation to first decompensation event, assessed up to 49 months). 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 24 Jul 2026.