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RECRUITING
NCT05895136
PHASE2

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-07-01

Completion Date

2025-09

Last Updated

2025-03-19

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

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

DRUG

Standard 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