RecruitingPhase 2NCT05895136

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


Sponsor

European Foundation for Study of Chronic Liver Failure

Enrollment

90 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Enoxaparin, a drug called Human albumin, and others for people with acute on chronic liver failure (aclf), decompensated cirrhosis of liver, and other related conditions. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman 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

DRUGEnoxaparin

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

DRUGStandard medical treatment

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


Locations(9)

Hôpital Beaujon

Clichy, France

Universitätsklinikum Aachen AöR

Aachen, Germany

Universität Münster

Münster, Germany

IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, Italy

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

Turin, Piedmont, Italy

Hospital Universitari Vall d'Hebron-VHIR

Barcelona, Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clínic de Barcelona-FCRB

Barcelona, Spain

Royal Free Hospital

London, United Kingdom

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NCT05895136


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