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New treatment option for Decompensated Cirrhosis and Ascites
Official title Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
ClinicalTrials.gov ID: NCT05056220
What this study is testing
What is Human albumin?
Human albumin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for decompensated cirrhosis and ascites.
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 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
- Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score \> 11)
See the full eligibility criteria
- 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
- 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
- Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score \> 11)
- Hepatic encephalopathy grade III-IV
- Current, planned or previous treatment with direct antiviral agents for hepatitis C virus (HCV) in the last six months Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.)
- Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A
- Presence or history of severe extra-hepatic diseases (e.g.,chronic renal failure requiring hemodialysis, severe heart disease (NYHA \> II); severe chronic pulmonary disease (GOLD Score ≥ C), severe neurological and...
- HIV positive or other condition associated with and/or requiring immunosuppression
- Previous liver or other transplantation
- Pregnancy
- Breastfeeding
- Patients who decline to participate, patients who cannot provide prior written informed consent due to other causes than hepatic encephalopathy or patients with hepatic encephalopathy who cannot provide prior written...
- Physician's denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)
- Participation in another study within 3 months prior to screening
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Herlev, Denmark
- Odense, Denmark
- Berlin, Germany
- Jena, Germany
- Münster, Germany
- Debrecen, Hungary
- Leiden, Netherlands
- Leiderdorp, Netherlands
- Barcelona, Spain
- London, United Kingdom
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Herlev, Denmark; Odense, Denmark; Berlin, Germany; Jena, Germany; Münster, Germany and 5 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.