Can a Two-Drug combo keep cirrhosis patients out of the hospital?
NCT ID NCT05895136
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing whether combining human albumin and enoxaparin is safe and effective for people with decompensated cirrhosis who are well enough to leave the hospital. The trial enrolls about 90 adults with severe liver scarring and recent complications. Participants receive either the combination plus standard care or standard care alone, and researchers track side effects and changes in disease severity scores over 90 to 180 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of human albumin and enoxaparin
- What this could lead to
- If it works, this combination could give doctors a new way to stabilize patients with decompensated cirrhosis after they leave the hospital, possibly reducing complications and readmissions.
- What could go wrong
- This is a small Phase 2 trial, so results may not hold in larger studies. Albumin can cause fluid overload and enoxaparin can cause bleeding, so safety is a key concern.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18 and 80 years. 2. Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive-related gastrointestinal bleeding, bacterial infection, or any combination of these). 3. CLIF-C AD score ≥ 45 at admission or at any time during hospital stay. 4. Recovery from AD and expected to be discharged within the next 72 hours. Exclusion Criteria: 1. Diagnosis of acute-on-chronic liver failure (ACLF) grade 3 or higher according to the EASL-CLIF criteria at admission or at any time during the index hospitalization 2. Admission for planned diagnostic or therapeutic procedures 3. Recent acute bleeding (unless the cause has been effectively treated and there is no evidence of ongoing bleeding for at least 5 days) 4. Chronic bleeding requiring periodic blood transfusions 5. Presence of an ongoing acute complication of the disease (i.e. hepatic encephalopathy \[grade III or IV\]) 6. Conditions with a high risk of haemorrhage, including haemorrhagic diathesis not related to liver disease 7. Patients with INR \> 3.0 8. Severe thrombocytopenia (\<30x10 9 /L) 9. Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions 10. Ongoing anti-platelets therapy. 11. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or non-melanocytic skin cancer) 12. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months 13. Ongoing alcohol use disorder with an expected low adherence to protocol as judged by physician 14. Previous liver transplantation 15. Patients with TIPS or other surgical porto-caval shunts 16. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \<30 ml/min according to the MDRD equations 17. Chronic heart failure NYHA class III or IV 18. Pulmonary disease GOLD III or IV 19. Patients with extrahepatic diseases with life expectancy \<6 months 20. Severe psychiatric disorders 21. Hypersensitivity to albumin preparations or to any of the excipients. 22. Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients 23. History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies 24. Pregnancy and breast-feeding 25. Expected low adherence to study protocol as judged by physician 26. Patients who can't provide written informed consent or refusal to participate 27. Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
COMPLETEDTurin, Piedmont, 10126, Italy
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Hospital Clínic de Barcelona-FCRB
COMPLETEDBarcelona, 08036, Spain
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Hospital Universitari Vall d'Hebron-VHIR
COMPLETEDBarcelona, 08035, Spain
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Hospital Universitario Ramón y Cajal
COMPLETEDMadrid, 28034, Spain
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Hôpital Beaujon
COMPLETEDClichy, 92110, France
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IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
RECRUITINGBologna, Emilia-Romagna, 40138, Italy
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Royal Free Hospital
WITHDRAWNLondon, NW3 2QG, United Kingdom
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Universität Münster
COMPLETEDMünster, 48149, Germany
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Universitätsklinikum Aachen AöR
COMPLETEDAachen, 52074, Germany
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