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