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New treatment option for Liver Cirrhosis
Official title A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
ClinicalTrials.gov ID: NCT05895136
What this study is testing
What is Human albumin?
Human albumin is an investigational medicine, being studied as a potential treatment for liver cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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...
- 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...
- 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
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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France
- Aachen, Germany
- Münster, Germany
- Bologna, Emilia-Romagna, Italy
- Turin, Piedmont, Italy
- Barcelona, Barcelona, Spain
- Madrid, Madrid, Spain
- Barcelona, Spain
- London, United Kingdom
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France; Aachen, Germany; Münster, Germany; Bologna, Emilia-Romagna, Italy; Turin, Piedmont, Italy; Barcelona, Barcelona, Spain and 3 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.