A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- To assess the safety and tolerability of the combinatorial therapy in terms of TEAE (pulmonary edema, major bleeding and/or thrombocytopenia — from baseline to Day 90
The safety and tolerability of the combinatorial therapy of human albumin and enoxaparin on top of SMT compared to SMT alone, from baseline to Day 90, will be evaluated as the percentage of subjects who discontinued the study drug due to at least 1 of the following treatment-emergent adverse events (TEAE): pulmonary edema, severe thrombocytopenia and/or major bleeding. These variables will be described (counts and percentage).
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 France
Other trials for the same condition
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 France