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Clinical Trials in Germany / NCT05895136
Recruiting Phase 2

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

NCT05895136 · tracked via the Priya Life Science Germany tracker
Sponsor
European Foundation for Study of Chronic Liver Failure
Phase
Phase 2
Started
2024-07-01
Last updated
2026-09-11

Condition(s) studied

Liver CirrhosisDecompensated Cirrhosis of LiverAcute on Chronic Liver Failure (ACLF)

Investigational drug(s) / intervention(s)

Human albumin →Enoxaparin →Standard medical treatment

Human albumin: Human albumin solution is made from pooled human plasma. It is widely used as a plasma-expander in several disease conditions, such as liver cirrhosis and critically ill patients. ATC-Code: B05AA01

Enoxaparin: Enoxaparin is a drug that belongs to the group of anticoagulants. It exerts its antithrombotic activity by binding to antithrombin III (AT III). ATC-Code: B01AB05

Standard medical treatment: SMT will be considered non-study medication and is not specified in the protocol.

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Hôpital Beaujon Clichy France Completed
Universitätsklinikum Aachen AöR Aachen Germany Completed
Universität Münster Münster Germany Completed
IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola Bologna Emilia-Romagna Recruiting
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino" Turin Piedmont Completed
Hospital Universitari Vall d'Hebron-VHIR Barcelona Spain Completed
Hospital Clínic de Barcelona-FCRB Barcelona Spain Completed
Hospital Universitario Ramón y Cajal Madrid Spain Completed
Royal Free Hospital London United Kingdom Withdrawn

More European Foundation for Study of Chronic Liver Failure trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05895136 on ClinicalTrials.gov ↗ ← All trials in Germany