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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 18 and 80 years.

• Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive-related gastrointestinal bleeding, bacterial infection, or any combination of these).

• CLIF-C AD score ≥ 45 at admission or at any time during hospital stay.

• Recovery from AD and expected to be discharged within the next 72 hours.

Locations
Other Locations
France
Hôpital Beaujon
RECRUITING
Clichy
Germany
Universitätsklinikum Aachen AöR
RECRUITING
Aachen
Universität Münster
RECRUITING
Münster
Italy
IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
RECRUITING
Bologna
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
RECRUITING
Turin
Spain
Hospital Clínic de Barcelona-FCRB
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron-VHIR
RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
United Kingdom
Royal Free Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Anna Bosch
anna.bosch@efclif.com
+34 93 227 14 03
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2025-09
Participants
Target number of participants: 90
Treatments
Experimental: Enoxaparin plus human albumin
Cohort 1 will receive standard medical treatment plus a combinatorial therapy of enoxaparin and human Albumin.
Active_comparator: Standard medical treatment
Cohort 2 (control) will receive only standard medical treatment.
Related Therapeutic Areas
Sponsors
Leads: European Foundation for Study of Chronic Liver Failure
Collaborators: Horizon 2020 - European Commission

This content was sourced from clinicaltrials.gov