A Novel COMBinATorial Therapy with Albumin and Enoxaparin in Patients with Decompensated Cirrhosis At High-risk of Poor Outcome (COMBAT Trial).

Last updated: March 14, 2025
Sponsor: European Foundation for Study of Chronic Liver Failure
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Failure

Liver Disease

Scar Tissue

Treatment

Human albumin

Standard medical treatment

Enoxaparin

Clinical Study ID

NCT05895136
COMBAT
  • Ages 18-80
  • All Genders

Study Summary

The goal of this clinical trial is to determine primarily whether a combinatorial therapy based on the administration of human albumin and enoxaparin is safe and effective in patients with decompensated cirrhosis discharged from the hospital. The main questions it aims to answer are:

  • Is this combinatorial therapy safe and tolerable?

  • Is this combinatorial therapy effective?

  • does this combinatorial therapy cost more or less than standard medical therapy? Participants will attend to study visits in which several test will be performed to asses disease evolution while they are taking study medication.

Researchers will compare experimental group treated with combinatorial therapy plus standard treatment with control group treated with standard treatment to see if there are differences in the responses to the questions raised above.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 and 80 years.

  2. Patients with decompensated cirrhosis admitted to hospital due to AD according tothe EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portalhypertensive-related gastrointestinal bleeding, bacterial infection, or anycombination 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

Exclusion Criteria:

  1. Diagnosis of acute-on-chronic liver failure (ACLF) grade 3 or higher according tothe 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 noevidence 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. hepaticencephalopathy [grade III or IV])

  6. Conditions with a high risk of haemorrhage, including haemorrhagic diathesis notrelated to liver disease

  7. Patients with INR > 3.0

  8. Severe thrombocytopenia (<30x10 9 /L)

  9. Ongoing chronic anticoagulation therapy or indication for starting anticoagulationdue to hepatic and non-hepatic conditions

  10. Ongoing anti-platelets therapy.

  11. Active malignancy (except for hepatocellular carcinoma within the Milan criteria ornon-melanocytic skin cancer)

  12. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months orplanned to be initiated in the following 6 months

  13. Ongoing alcohol use disorder with an expected low adherence to protocol as judged byphysician

  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 otherlow 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 frominformed consent signature.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Human albumin
Phase: 2
Study Start date:
July 01, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Hôpital Beaujon

    Clichy, 92110
    France

    Active - Recruiting

  • Universitätsklinikum Aachen AöR

    Aachen, 52074
    Germany

    Active - Recruiting

  • Universität Münster

    Münster, 48149
    Germany

    Active - Recruiting

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

    Bologna, Emilia Romagna 40138
    Italy

    Active - Recruiting

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

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Hospital Clínic de Barcelona-FCRB

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron-VHIR

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Site Not Available

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