Can a Two-Drug combo keep cirrhosis patients out of the hospital?

NCT ID NCT05895136

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute on chronic liver failure (ACLF) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure cirrhosis of liver liver disorder

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"

    COMPLETED

    Turin, Piedmont, 10126, Italy

  • Hospital Clínic de Barcelona-FCRB

    COMPLETED

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron-VHIR

    COMPLETED

    Barcelona, 08035, Spain

  • Hospital Universitario Ramón y Cajal

    COMPLETED

    Madrid, 28034, Spain

  • Hôpital Beaujon

    COMPLETED

    Clichy, 92110, France

  • IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Royal Free Hospital

    WITHDRAWN

    London, NW3 2QG, United Kingdom

  • Universität Münster

    COMPLETED

    Münster, 48149, Germany

  • Universitätsklinikum Aachen AöR

    COMPLETED

    Aachen, 52074, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.