A Phase 2 interventional study of Human albumin and Enoxaparin in Liver Cirrhosis, Decompensated Cirrhosis of Liver and Acute on Chronic Liver Failure (ACLF), sponsored by European Foundation for Study of Chronic Liver Failure. Recruiting at 9 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by European Foundation for Study of Chronic Liver Failure · Phase 2, Interventional, and Treatment
Among 76 studies in Liver Cirrhosis with a site in Spain — 16 open to participants now, 20 under way, 3 of them phase 3. Liver Cirrhosis · Spain.
Among the 76 studies in Liver Cirrhosis with a site in Spain, this one is the 23rd largest by planned enrollment of the 50 interventional ones, is one of 9 that started in 2024, is one of 20 in phase 2, reaches primary completion later than 4 of the 19 other live ones, and was the 64th registered.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 90 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →16 of the 76 studies in Liver Cirrhosis with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 208 Liver Cirrhosis studies recruiting now, 101 (49%) set no upper age limit and 66 (32%) stop at 75 or younger; 12 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →76 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 9 started in 2024.
Median enrollment 76 across the 50 interventional studies, 334 across the 26 observational. Of the 47 that completed or were terminated, 13 (28%) have results posted.
29 of 76 have an industry lead sponsor. The 10 most frequent:
European Foundation for Study of Chronic Liver Failure is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
European Foundation for Study of Chronic Liver Failure has 3 studies filed under Liver Cirrhosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Liver Cirrhosis with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05500222Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) | 2026-12 |
| NCT04971577Phase 3Anna CrucetaEfficacy of Simvastatin in Alcoholic Liver Fibrosis | 2027-03 |
| NCT06664307Hospital Universitario Virgen MacarenaEvaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis. | 2026-11-01 |
| NCT07585890University Medical Center GroningenEstablishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe | 2026-12-31 |
| NCT04613921European Foundation for Study of Chronic Liver FailureLiver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs | 2026-12-31 |
Among the 76 studies in Liver Cirrhosis with a site in Spain, from their registry updates:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1 will receive standard medical treatment plus a combinatorial therapy of enoxaparin and human Albumin.
Drug: Human albumin · Drug: Enoxaparin · Drug: Standard medical treatment
Cohort 2 (control) will receive only standard medical treatment.
Drug: Standard medical treatment
Human albumin solution is made from pooled human plasma. It is widely used as a plasma-expander in several disease conditions, such as liver cirrhosis and critically ill patients. ATC-Code: B05AA01
Enoxaparin is a drug that belongs to the group of anticoagulants. It exerts its antithrombotic activity by binding to antithrombin III (AT III). ATC-Code: B01AB05
SMT will be considered non-study medication and is not specified in the protocol.
To assess the safety and tolerability of the combinatorial therapy in terms of TEAE (pulmonary edema, major bleeding and/or thrombocytopenia
The safety and tolerability of the combinatorial therapy of human albumin and enoxaparin on top of SMT compared to SMT alone, from baseline to Day 90, will be evaluated as the percentage of subjects who discontinued the study drug due to at least 1 of the following treatment-emergent adverse events (TEAE): pulmonary edema, severe thrombocytopenia and/or major bleeding. These variables will be described (counts and percentage).
Time frame: from baseline to Day 90
90 and 180-days changes in prognostic scores of CLIF-Consortium Acute Decompensation score (CLIF-C AD) from baseline.
Lower scores of CLIF-C AD (\<45) indicate a better prognostic than greater values (\>50). In the statistical analysis Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in prognostic scores of Mayo End stage Liver Disease (MELD) from baseline.
The MELD score ranges from six to 40 and is based on results from several lab tests. The higher the number, the more likely you are to receive a liver from a deceased donor when an organ becomes available. Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in prognostic scores of Mayo End stage Liver Disease - sodio (MELDNa) from baseline
The MELDNa score ranges from six to 40 and is based on results from several lab tests. The higher the number, the more likely you are to receive a liver from a deceased donor when an organ becomes available. Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
30 days, 90 and 180-days incidence of hospital readmission and ICU admission (causes and length of stay)
Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 30, 90 and 180-days
90 and 180-days incidence of ACLF according to the EASL-CLIF criteria
Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days overall and transplant-free survival
Overall and transplant-free survival will be analyzed by estimating Kaplan-Meier survival curves for each treatment arm. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days incidence and cumulative number of therapeutic paracenteses
Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days incidence of major complication of cirrhosis (grade 2-4 HE, portalhypertensive gastrointestinal bleedings, AKI, HRS-AKI, new-onset portal vein thrombosis)
Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days incidence of proven bacterial infection
Chi-Square test or Fisher exact test will be performed. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: liver function variables: grade of ascites
Grade of ascites according to the criteria of the International Club of Ascites. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: liver function variables: grade of hepatic encephalopathy (West Haven)
Grade of hepatic encephalopathy using the West Haven (score range 0, normal to 4, coma). Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: liver function variables: grade of hepatic encephalopathy (ANT)
Animal Naming Test (ANT): range from \>15, normal to \<10 Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: liver function variables: bilirrubin
Bilirubin in mg/dL. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: liver function variables: albumin serum levels
Albumin serum levels in g/dL. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: renal function variables: BUN
BUN in mg/dL. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: renal function variables: serum creatinine
Serum creatinine in mg/dL. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: renal function variables: electrolites
Electrolytes: Na, K, Ca (mmol/L). Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: renal function variables: GFR
Glomerula Filtration Ratio (GFR) will be estimated by the Modification of Diet in Renal Disease (MDRD) equations. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: lung function variables: respiratory rate
Respiratory rate in breaths per minute. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: lung function variables: FIO2
Fraction of inspired oxygen (FIO2) in percentage (%). Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: lung function variables: pulse oxymetric saturation
Pulse oxymetric saturation in percentage (%). Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: coagulative variables: INR
International Normalized Ratio (INR). Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: coagulative variables: aPTT
Activated partial thromboplastin time (aPTT) in seconds. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: coagulative variables: fibrinogen
Fibrinogen in mg/dL. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: coagulative variables: Platelet count
Platelet count in platelets per microliter. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: hemodynamic variables: arterial pressure
Systolic, diastolic and mean arterial pressure in mmHg. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in organ function from baseline: hemodynamic variables: heart rate.
Heart rate in beats per minute. Ranges according reference ranges of each study site. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in frailty (Liver Frailty Index, LFI)
LFI score of ≤ 3.2 indicates a patient is robust, 3.3-4.4 pre frail and ≥ 4.5 frail. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in quality of life measure through European Quality of Life Five Dimension Five Levels (EQ-5D-5L)
EQ-5D-5L has a score from 5 (no problems) to 25 (extreme problems on all dimensions evaluated). Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
90 and 180-days changes in quality of life measure through Visual Analog Scale (VAS)
VAS has a score from 0 (worst health patient can imagine) to 100 (best health patient can imagine) Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 90 and 180-days from baseline
Total hospital costs during the 6-month period
To estimate the 90-days costs of an acute decompensation of cirrhosis for both arms in the trial In-hospital resource utilization will be described based on diagnosis and procedural codes and length of stay. Hospital costs will be assigned based on the primary indication for hospitalization and procedures performed during the hospitalization and the Severity-Diagnosis Related Groups. Costs will be then assigned based on the latest mean cost available. Costs will be calculated in euros by treatment arm. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 180-days from baseline
Total hospital costs predictors during the 6-month period
To identify cost predictors (patients characteristics that are present before the treatment is initiated) and In-hospital resource utilization will be described based on diagnosis and procedural codes and length of stay. Hospital costs will be assigned based on the primary indication for hospitalization and procedures performed during the hospitalization and the Severity-Diagnosis Related Groups. Costs will be then assigned based on the latest mean cost available. Costs will be calculated in euros by treatment arm. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 180-days from baseline
Total hospital costs drivers during the 6-month period cost drivers
Cost drivers (response to treatment, randomization arm, other treatments). In-hospital resource utilization will be described based on diagnosis and procedural codes and length of stay. Hospital costs will be assigned based on the primary indication for hospitalization and procedures performed during the hospitalization and the Severity-Diagnosis Related Groups. Costs will be then assigned based on the latest mean cost available. Costs will be calculated in euros by treatment arm. Student t-test or analysis of variance will be used to compare normally distributed variable or non-parametric methods if the assumptions of normality are not met. Pairwise Log-rank tests will be used for statistical comparisons.
Time frame: 180-days from baseline
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Plan to share: No — Only aggregated data will be shared among sites.
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Oct 2026, 27 months after the start.
Of 55 phase 2 interventional studies under Liver Cirrhosis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 56. This study's planned 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Enoxaparin
European Foundation for Study of Chronic Liver Failure