NCT05895136

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: European Foundation for Study of Chronic Liver Failure · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis
• Decompensated Cirrhosis of Liver
• Acute on Chronic Liver Failure (ACLF)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-06-08
• Last updated: 2025-03-19

Locations

9 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom