Personalized treatment with human albumin for patients with liver cirrhosis and fluid buildup
A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker
This study is testing if a special set of blood markers can help doctors find out which patients with liver cirrhosis and fluid buildup will benefit most from regular infusions of human albumin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 12 sites (Leuven and 11 other locations) |
| Trial ID | NCT05056220 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a predictive biomarker panel in identifying patients with decompensated cirrhosis and ascites who are likely to benefit from regular human albumin infusions. Participants will be stratified based on the biomarker panel into high- or low-expected effect groups and will receive either human albumin or sodium chloride infusions over a six-month period. The study seeks to determine if the biomarker can reduce the number of patients needed to treat to achieve beneficial outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with decompensated liver cirrhosis and clinically evident ascites.
Not a fit: Patients with acute liver failure, refractory ascites, or severe alcoholic hepatitis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with liver cirrhosis and ascites.
How similar studies have performed: Previous studies have shown promise in using biomarker panels for treatment stratification, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 psychiatric disorders, pulmonary arterial hypertension) * 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 informed consent and when there is documented evidence that the patient has no legal surrogate decision maker or sufficient ability to provide delayed informed consent * 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
Where this trial is running
Leuven and 11 other locations
- Katholieke Universiteit Leuven — Leuven, Belgium (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Germany (Recruiting)
- Universitätsklinikum Münster — Münster, Germany (Recruiting)
- Debreceni Egyetem — Debrecen, Hungary (Recruiting)
- Academisch Ziekenhuis Leiden — Leiden, Netherlands (Recruiting)
- Alrijne Ziekenhuis Leiden — Leiderdorp, Netherlands (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
- Hospital Del Mar — Barcelona, Spain (Recruiting)
- King's College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Aleksander Krag, Professor — Odense University Hospital
- Study coordinator: Aleksander Krag, Professor
- Email: albtrial@rsyd.dk
- Phone: +4566113333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.