A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
Key facts
- Where
- Bologna and Turin, ItalySee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05895136, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- European Foundation for Study of Chronic Liver Failure
- Trial code
- NCT05895136EU 2023-507073-18-00
- Record updated
- 11 September 2026
- Original description
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:Read full original descriptionShow less
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.
Inclusion: Age between 18 and 80 years; 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); CLIF-C AD score ≥ 45 at admission or at any time during hospital stay; Recovery from AD and expected to be discharged within the next 72 hours.
Exclusion: Previous liver transplantation; Patients with TIPS or other surgical porto-caval shunts; Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature; 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; Recent acute bleeding (unless the cause has been effectively treated and there is no evidence of ongoing bleeding for at least 5 days); Chronic bleeding requiring periodic blood transfusions; Presence of an ongoing acute complication of the disease (i.e. hepatic encephalopathy [grade III or IV]); Conditions with a high risk of haemorrhage, including haemorrhagic diathesis not related to liver disease; Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions; Active malignancy (except for hepatocellular carcinoma within the Milan criteria or non-melanocytic skin cancer); Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months; Ongoing alcohol use disorder with an expected low adherence to protocol as judged by physician; Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate <30 ml/min according to the MDRD equations; Chronic heart failure NYHA class III or IV; Pulmonary disease GOLD III or IV; Patients with extrahepatic diseases with life expectancy <6 months; Severe psychiatric disorders; History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies; Patients with INR > 3.0; Severe thrombocytopenia (<30x10 9 /L); Ongoing anti-platelets therapy; Hypersensitivity to albumin preparations or to any of the excipients; Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients; Admission for planned diagnostic or therapeutic procedures; Pregnancy and breast-feeding; Expected low adherence to study protocol as judged by physician; Patients who can't provide written informed consent or refusal to participate.