At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Human albumin (drug), sodium chloride (drug)
- How long the study runs
- Study runs about 31 months (dates as stated)
- About the drug or intervention
- Human albumin — drug: 20% Human Albumin infusions (every 10th day +/- 4 days) with dosing according to the participants bodyweight (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams) · sodium chloride — drug: 0.9% NaCl infusions (every 10th day +/- 4 days) with dosing according to the corresponding volume used of 20% Human Albumin (1.5 grams of albumin per kg bodyweight with a maximum of 100 grams)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at long-term treatment with human albumin (a blood protein given through a drip) in people with decompensated cirrhosis and ascites. Cirrhosis is scarring of the liver, and ascites means fluid building up in the tummy. The study is sponsored by Aleksander Krag.
Who can take part
- Adults aged 18 or over
- Scarring of the liver (cirrhosis) with a Child-Pugh score of 7 to 12, meaning the liver is not working well
- Fluid in the tummy (ascites) shown by examination or an ultrasound scan
- At least five days since recovery from a flare-up of liver disease or any stay in hospital
Who may not be able to
- Sudden liver failure without underlying cirrhosis
- Liver problems that started after surgery to remove part of the liver
- Ascites that no longer responds to treatment (refractory ascites)
- A TIPS (a tube placed in the liver to reduce fluid build-up) put in within the last 6 months
- A blood clot in the main vein of the liver without signs of the body clearing it
- Severe alcoholic hepatitis with a Glasgow Alcoholic Hepatitis Score above 11
- Severe confusion caused by liver disease (grade III-IV hepatic encephalopathy)
- Treatment with direct antiviral medicines for hepatitis C now, in the past 6 months, or planned
- Reasons why albumin cannot be given safely, such as fluid on the lungs or allergy
- Cancer, apart from some skin cancers and very early liver cancer (BCLC-0 or BCLC-A)
- Serious other illnesses, such as kidney failure needing dialysis, severe heart disease (NYHA above II), severe lung disease (GOLD Score C or above), severe brain or mental health conditions, or high blood pressure in the lungs
- HIV or any other condition needing treatment that weakens the immune system
- Previous liver or other organ transplant
- Pregnancy or breastfeeding
- Not being able to agree to take part, with no legal representative able to agree on the person's behalf
- The doctor believes the person would not follow the study plan, for example due to heavy drinking
- Taking part in another study within the past 3 months
What taking part involves
- • Long-term treatment with human albumin, a protein given through a drip into a vein
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 240
- Started
- 2024-02-26
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for decompensated cirrhosis and ascites
- • Phase3 - 240 participants
- • The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with decompensated cirrhosis and ascites
Where?
- • London - King's College Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are: * If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions * If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites The predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms. Participants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study. Researchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Decompensated liver cirrhosis defined as Child-Pugh score 7-12
- ✓Clinical and/or ultrasound evidenced ascites
- ✓Age ≥ 18 years
- ✓At least five days since resolution of a decompensation event or any condition requiring hospitalisation
Who cannot take part
- ✗Patients with acute or subacute liver failure without underlying cirrhosis
- ✗Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
- ✗Refractory ascites as defined by the International Ascites Club
- ✗Existing TIPS inserted \<6 months ago
- ✗Portal vein thrombosis without signs of cavernous transformation or recanalization
See the full criteria
Where Is This Study? (1 UK site)
King's College Hospital
London, United Kingdom
How to Get in Touch
Aleksander Krag, Professor
Sponsor contactCONTACT
Jonel Trebicka, Professor
Sponsor contactCONTACT