Status:

RECRUITING

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

Lead Sponsor:

European Foundation for Study of Chronic Liver Failure

Collaborating Sponsors:

Horizon 2020 - European Commission

Conditions:

Liver Cirrhosis

Decompensated Cirrhosis of Liver

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief 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 decompensat...

Eligibility Criteria

Inclusion Criteria:

  1. Age between 18 and 80 years.
  2. 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).
  3. CLIF-C AD score ≥ 45 at admission or at any time during hospital stay.
  4. Recovery from AD and expected to be discharged within the next 72 hours.

Exclusion Criteria:

  1. Diagnosis of acute-on-chronic liver failure (ACLF) grade 3 or higher according to the EASL-CLIF criteria at admission or at any time during the index hospitalization
  2. Admission for planned diagnostic or therapeutic procedures
  3. Recent acute bleeding (unless the cause has been effectively treated and there is no evidence of ongoing bleeding for at least 5 days)
  4. Chronic bleeding requiring periodic blood transfusions
  5. Presence of an ongoing acute complication of the disease (i.e. hepatic encephalopathy [grade III or IV])
  6. Conditions with a high risk of haemorrhage, including haemorrhagic diathesis not related to liver disease
  7. Patients with INR > 3.0
  8. Severe thrombocytopenia (<30x10 9 /L)
  9. Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions
  10. Ongoing anti-platelets therapy.
  11. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or non-melanocytic skin cancer)
  12. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months
  13. Ongoing alcohol use disorder with an expected low adherence to protocol as judged by physician
  14. Previous liver transplantation
  15. Patients with TIPS or other surgical porto-caval shunts
  16. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate <30 ml/min according to the MDRD equations
  17. Chronic heart failure NYHA class III or IV
  18. Pulmonary disease GOLD III or IV
  19. Patients with extrahepatic diseases with life expectancy <6 months
  20. Severe psychiatric disorders
  21. Hypersensitivity to albumin preparations or to any of the excipients.
  22. Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients
  23. History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies
  24. Pregnancy and breast-feeding
  25. Expected low adherence to study protocol as judged by physician
  26. Patients who can't provide written informed consent or refusal to participate
  27. Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature.

Key Trial Info

Start Date :

July 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2025

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT05895136

Start Date

July 1 2024

End Date

September 1 2025

Last Update

March 19 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Hôpital Beaujon

Clichy, France, 92110

2

Universitätsklinikum Aachen AöR

Aachen, Germany, 52074

3

Universität Münster

Münster, Germany, 48149

4

IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, Italy, 40138