Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Recruiting
Phase 3
Interventional Study
Decompensated Cirrhosis and Ascites
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Aleksander Krag · Other
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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…
Trial Locations
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Eligibility 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…
Contacts
Jonel Trebicka, Professor
CONTACT