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A novel COMBinATorial therapy with albumin and enoxaparin in patients with decompensated cirrhosis at high-risk of poor outcome (COMBAT trial).
EU CTIS ID: 2023-507073-18-00
What this study is testing
To assess the safety and tolerability of the combinatorial therapy (human albumin and enoxaparin) in terms of TEAE (pulmonary edema, major bleeding and/or thrombocytopenia).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
- 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
See the full eligibility 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.
- 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
- 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
- Admission for planned diagnostic or therapeutic procedures
- 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.
- 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 (<30x109/L)
- Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.