drugset / Trial / NCT05895136

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

NCT05895136 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-01
Primary completion
2026-10-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified — —
Subject Human Albumin Protein / enzyme biologic — —